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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: ¿ (b)(6) 2011: [facility ni] [not indicated].(b)(6), md.Office notes.Had seen for small ventral hernia on (b)(6); had put him off because of chest pain and pressure which was new.Apparently, has been cleared by dr.(b)(6)¿s office but no documentation yet.Was in (b)(6) this weekend at a concert and developed pain in abdomen; having sharp pains throughout abdomen.Having loose stools.Do not believe he has had much vomiting, has been nauseated.Girlfriend noted hernia seemed to be quite tender.Exam: abdomen soft, mild tenderness throughout without guarding.Hernia a bit tender but seems to reduce fairly easily.No palpable masses.Impression: abdominal pain of questionable cause.Doubt related to hernia but will check flat and upright abdominal films, cbc and crp as well.See back in 2 days.Might see about getting him on surgery schedule for this coming friday.¿ (b)(6) 2011: [facility ni].(b)(6), md.Office notes.Feeling better.Not having near the abdominal pain and cramping that he was and diarrhea better.X-rays pretty much unremarkable.Blood work did not show anything of note.Cleared for surgery by dr.(b)(6); passed stress test.Plan: get set up for ventral hernia repair this friday.¿ (b)(6) 2011: (b)(6) medical health system.[signature illegible].Anesthesia preoperative assessment.Wt.260 lbs.Surgical history: appendectomy.Smokes.Gastroesophageal reflux disease, obesity.Asa class 2.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6), md.Operative report.Preoperative diagnosis: symptomatic ventral hernia.Postoperative diagnosis: symptomatic ventral hernia.Procedure: reduction of ventral hernia with repair with a 2-1/2-inch ventralex patch.Indication for procedure: the patient presented with symptomatic ventral hernia.It was fairly large.I could not tell how big the exact defect was.Description of procedure: ¿the patient was placed on the table in a supine position.General endotracheal anesthesia was administered.The abdomen was prepped and draped in the usual sterile fashion with chloraprep after hair was removed with electric clippers.An incision was made over the mass and carried down through skin and subcutaneous tissue.We got into the plane of the hernia sac and dissected around to its vascular reflection.I then made an incision at the base of the hernia sac, got into it, and cauterized it and clamped the sac pedicles.I did this after i had freed up the omentum from the hernia sac and restored it to its anatomic position.I measured the defect.It was 2 x 2.5 cm.At that point, i selected a 2-1/2-inch ventralex patch, inserted it, and made sure the edges were flush with the abdominal wall.It was then anchored into position with interrupted 3-0 nurolon sutures in the retaining strap upper and lower and then i cut the straps and folded them over and we had another layer anchoring the straps to each other in the middle and anchoring them to the edge of the fascial defect.The wound was irrigated out with antibiotic solution and closed with interrupted subcutaneous sutures and 3-0 nylon skin sutures, vertical mattress, and simple.The patient tolerated the procedure well and was returned to the recovery room in good condition.¿ ¿ (b)(6) 2011: (b)(6) medical health system.Implant sticker.Bard 3dmax mesh.Implant record.Mesh ventralex medium.Manufacturer: bard, inc.¿ (b)(6) 2011: owensboro medical health system.(b)(6).Radiology ¿ abdomen series with chest.Indication: abdominal pain.Impression: normal abdominal series with chest x-ray.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6) radiology ¿ ct abdomen/pelvis with intravenous contrast.Indication: abdominal pain, left lower quadrant pain, headache, constipation, hernia repair three weeks ago.Impression: left lower quadrant pericolonic abscess along the diverticular sigmoid colon.May represent diverticular abscess from diverticulitis, or a post-surgical abscess.Walls of abscess somewhat irregular, and the encapsulation may not yet be completely formed.Air/fluid level inside a peri-umbilical hernia cavity, entirely located within the subcutaneous tissues between the anterior abdominal wall and the skin surface.There may be an underlying hernia mesh, versus fascial thickening or post-surgical change in the underlying connective tissues.Background of left colon diverticulosis.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6), pa-c.History and physical.1 to 1 ½ week history of intermittent, sharp, stabbing pain in left lower quadrant.Has not thrown up, not nauseated at this time, no appetite.Last bowel movement 1 week ago.Hurts to urinate, had low-grade fever.Ct abdomen shows left lower quadrant peri-colonic abscess along with diverticular sigmoid colon, which represents a diverticular abscess from diverticulitis.Unrelated ventral hernia repair 3 weeks ago; incision doing well, no complications.Wt.250 lbs.Abdomen soft, nondistended, tender left lower quadrant, no hernias noted.Incision from surgery 3 weeks ago healing well.Impression/plan: left lower quadrant pain, diverticulitis.Recent ventral hernia repair, doing well from that standpoint.Hopefully, best case scenario is to treat with intravenous antibiotics, undergo colonoscopy in next several weeks.Worst case scenario, he would be candidate for surgical repair with temporary colostomy.On zosyn and colace as well as morphine as needed.Continue zosyn and observation.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6).Radiology ¿ ct guided drainage of diverticular abdominal abscess.History: abdominal abscess.Impression: successful aspiration of anterior superficial periumbilical postoperative fluid collection where fluid was removed and samples sent to the laboratory for culture and sensitivities.Successful drainage and placement of drainage catheter into a peri-colonic abscess cavity in the anterior left pelvis.Sample was sent to laboratory for culture and sensitivity.Catheter placed to drainage.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6), md.Consultation.Found to have ruptured diverticulum with anterior abscess above sigmoid colon.Had percutaneous drain placed in abscess and on intravenous antibiotics; now set for exploration with probable partial colectomy.Asked to see patient to place ureteral stents.Recent ventral hernia repair approximately 4 weeks ago.He does smoke.Abdomen has healing midline epigastric incision and right lower quadrant appendectomy incision.Impression: diverticular abscess.Will do cystoscopy to place bilateral ureter catheters to help identify ureters.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6), md.Operative report.Preoperative diagnosis: diverticulitis with pelvic abscess.Phimosis with meatal stenosis.Postoperative diagnosis: diverticulitis with pelvic abscess.Phimosis with meatal stenosis.Procedure performed: dilation of meatus.Cystoscopy with bilateral ureteral catheter placement.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6), md.Operative report.Preoperative diagnosis: perforated sigmoid diverticulitis with abscess.Postoperative diagnosis: perforated sigmoid diverticulitis with abscess.Abscess had been drained nicely.We did not really see much pus.Procedure: hand-assisted laparoscopic sigmoid resection with primary anastomosis.Indications for procedure: the patient had about a week of abdominal pain.He presented with elevated temperature, elevated white count, very tender lower abdomen.Radiology was able to get a catheter into the collection and drain it, and on iv antibiotics he gradually cooled off to where we could do a gentle bowel prep on him.He presents at this time for sigmoid resection.Procedure: ¿the patient was placed on the table in the supine position.General endotracheal anesthesia was administered.He was placed in los stirrups.Dr.(b)(6) placed urinary catheters up.I then made sure he was adequately positioned and placed up on a small pillow.He was appropriately padded and restrained.The abdomen was prepped and draped in the usual sterile fashion with hibiclens.Incision was made with my wrist centered over the umbilicus vertical fashion.Incision was carried down through skin and subcutaneous tissue.Midline fascia was identified and incised and the abdomen was entered without problem.The wound was gradually enlarged to where i could get my hand in.He did have some adhesions to the patch that had fixed his hernia and the patch seemed to be well in place.Adhesions were bluntly dissected off.He also had some adhesions in the pelvis and right lower quadrant presumably from his appendicitis a number of years ago.The gelport was placed.I then placed a 12 mm port in the midline lower and 5 mm in the right upper quadrant.We subsequently placed another 5 mm in the left upper quadrant under visualization.The colon was adherent to the abdominal wall.It was easily dissected down after i tried to do a medial to lateral dissection; however, his avascular plane was not very well defined.So we ended up simply taking the colon off the abdominal wall and incising the peritoneal reflections going up to the splenic flexure and swinging the colon down for mobility sake.We had a mass about 2/3 the size of my fist.No pus was spilled that i could see during the case.No stool was spilled.We gradually elevated the colon, dividing the peritoneum down either side of the sigmoid colon toward the pelvis.Once we got a fair amount of this dissected up we pulled the colon out through the port base and divided it using a gia in divided part of the mesocolon distally from the outside.Both ends of the colon were then returned to the abdominal cavity and the distal dissection was affected by dividing the mesocolon using 3 different vascular staples loads.We then dissected down to where the colon had a good appearance.It was apparent if we took it just below the pelvic brim we would need a stealth which is what we ended up using, stealth 29 mm.The colon was divided with a thick load, placed through the lower 12 mm port, and it was delivered from the abdominal cavity.I marked the distal end with a suture.The proximal end was brought up.There was a lot of fatty tissue on it.This was dissected free.We then took the stealth end plug inserted into the colon with the blue pointed end in the tip of the eea.We stapled across the colon and brought the pointed end out.In trying to remove it from the tip it broke, and we were unable to get it out so we had to open the colon up, got a different end and put it in and did a 2-0 pursestring prolene suture.This gave good approximation.The colon was returned to the abdominal cavity.The pelvis was thoroughly irrigated out and ms.Sexton went below and used a rectal manipulator to get up to where i was and the passed the stealth up and we came out the top side of the colon and then secured the tip to it.I kept extraneous tissue of the way, and we cranked down the eea and waited and then tightened it a little bit more, waited and tightened it a little bit more and then fired it.We had 2 very adequate donuts.I held the colon closed, filled the pelvis full of saline and ms.Sexton ran the colonoscope up noting an intact anastomosis and no bubbling.The pelvis was then irrigated and was then aspirated.We then irrigated everything out with antibiotic solution.There was no significant bleeding note.The lap sponge that had been placed in the abdomen was removed.The 2 upper ports were removed under visualization noting no bleeding.The lower port was closed with single figure-of-eight 0 vicryl suture.Then the midline wound was closed with running loop 0 nylon and wound was irrigated out.Skin staples were applied to all the wounds.Patient tolerated the procedure well.¿ estimated blood loss: 200-250 ml.Complications: none.Drains: none.Assistant: (b)(6), cfa.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6).Radiology ¿ (b)(6).Indication: rule out anastomotic leak.Impression: small leak noted along the medial aspect of the sigmoid colon at or near the anastomotic site.Sigmoid diverticulosis.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6).Radiology ¿ ct abdomen with/without contrast, ct pelvis with contrast.Indication: abdominal abscess.Findings: surgical wound in midline of the lower abdomen with trace fluid and air collection deep to the rectus sheath, which may represent a postoperative seroma or abscess formation.Impression: colonic leak at or near the anastomotic site in sigmoid colon with multiloculated fluid collection in lower abdomen and pelvis compatible with abscess and/or contained leak with edema or inflammatory changes throughout the adjacent fat.Trace extraluminal air within the peri-colonic fat and trace pneumoperitoneum, which in part is likely still postoperative.Air within urinary bladder; non-specific.Small loculated air and fluid collection deep to the rectus muscle at the incision site; could potentially represent small postoperative hematoma or abscess.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6), md.Operative report.Preoperative diagnosis: leaking colonic anastomosis.Postoperative diagnosis: leaking colonic anastomosis.Small right lower quadrant hernia from previous appendectomy incision.Procedure: central line insertion.Exploratory laparotomy with washout of abdominal cavity, takedown of previous anastomosis with resection of part of the proximal segment of the sigmoid colon.Formation of end sigmoid colostomy with oversewing of the distal anastomotic site and repair of a small hernia in the right lower quadrant from previous appendectomy.Removal of ventralex patch.Assistant: (b)(6), md.Estimated blood loss: 500 ml.Complications: none.Drains: a 19-french blake drain in the pelvis.Indications for procedure: the patient had presented with perforated sigmoid diverticulitis.He was placed on iv antibiotics and really did not start cooling off until we had the abscess draped [sic] percutaneously by dr.(b)(6).He did a nice job on this, and once that happened the patient¿s pain and discomfort went away, and we were able to start feeding him.We waited until he was afebrile and his white count was normal and he was quite a bit less tender.It then took essentially 3 days to slowly bowel prep him for hopefully a sigmoid resection with primary anastomosis.This was done on monday, (b)(6), 2011.He did well through wednesday night when he started having some fever.We got a gastrografin enema on him today which showed a very small leak, and a subsequent ct scan showed some gas bubbles in the area of the anastomosis as well as some extracolonic contrast.This was not a massive leak.On the initial bolus of the gastrografin, nothing really showed.It was not until subsequent films that a small area of leakage was noted.However, his white count was up around 21,000.He had been spiking fevers, and it was felt that we were going to have to deal with this and probably do some sort of diverting procedure.Description of procedure: ¿the patient was placed on the table in the supine position.General endotracheal anesthesia was administered.I then capped, gowned, masked, and gloved and prepped his right neck, visualized the jugular vein, and inserted a needle into the jugular vein on the 1st pass, followed by a guide wire, followed by the dilator, followed by the internal jugular catheter, anchored it roughly at 16 cm.Good blood return was noted.The ports were then irrigated out.Sterile dressings were applied after it was fixed in place.We then put him in low stirrups.He had already been given heparin and had scds on.His abdomen was then prepped and draped in the usual sterile fashion.I opened the midline including the previous site of his ventral hernia repair that had been done with the ventralex patch.Because of contamination of his abdomen i did not trust having a foreign body present.The abdomen was entered and incision was made from the upper midline down to the pubis.He had a large phlegmon present in the pelvic area.There was some murky fluid present, but there was not a lot of abdominal soilage present.There was no frank stool noted down in this area.However, it was quite inflamed.In dissecting around over his anastomosis, 2 inches of the colon were avulsed.A noncrushing clamp was placed proximally and the distal end we closed with interrupted 2-0 prolene sutures because there was really no good way to dissect out more colon in the face of all this inflammation without any urinary catheters in.It should be remembered that he had a stealth 29 mm anastomosis performed, and this came out on the anterior aspect of the colon about 2-3 cm below where the colon had been stapled off during the previous procedure.This had given a good anastomosis before with good donuts.The exact cause of the failure was not really identified.We never got a chance to insert any air from below to check the oblique side, and there was some swelling in there, it was impossible to try to close it and probably not safe to do that anyhow.There is a small chance he could have had a leak not so much from the anastomosis but from the stapled closure of the distal sigmoid segment, but again this is not known.There is still a little of the colon that is angulated over to the right-hand side above the site where we closed the anastomosis.Once this was done, i freed up the colon and proceeded up and took the omentum down off the distal transverse colon and helped swing it down to where there was enough freedom to swing the colon up through his abdominal wall.I had the stoma nurse stop by the holding area, and we marked a potential stoma site.There was a fair amount of inflammatory change in the distal segment of the colon, and about another fist-sized piece of sigmoid colon was removed.Basically we stapled across this.The mesocolon was divided between clamps as well as with the harmonic scissors.His colon is rather fatty.He had several large appendix epiploicae.We had to remove several of these in order to even get the bowel to go through the colostomy site.This was in the left lower quadrant.A circle of skin had been removed from there.The rectus muscle was split after a cruciate incision was made in the fascia.It took several attempts to finally get the colon through there.It looked a little dusky but not too bad.There was no significant tension noted.We had done a fair amount of dissection up, swinging the colon down using the harmonic up there.We then took stock of the abdominal cavity.He had a long omental adhesion that went down to the pelvis as well as the right lower quadrant where he had previous appendectomy.There was a small hernia that was full of omental fat, and we dissected that and a large wad of omentum that was adherent in this area.This was a long tongue of omentum that made a rather dangerous-looking band that he could have problems with.There is a loop of small bowel that is down parallel to the sigmoid colon.Nothing seemed to be obstructed in this area, so i did not elevate it because another piece of colon would simply take its place.Once the wad of omentum was dissected out of the right lower quadrant, the small hernia was repaired with 3 interrupted #1 prolene sutures from the inside.The wound was then thoroughly irrigated out.We amputated a little bit more omentum as it had several holes in it.All sponges were removed from the abdominal cavity.We used 3 l of bacitracin solution to irrigate the abdomen, taking care to get fluid up over the spleen and aspirate it.The colon had been previously brought out through the abdominal wall, and the abdomen was closed with 2 seprafilms placed over the small bowel since we did not have a lot of omentum left to place in front of the small bowel.I chose to close the abdomen with #1 prolene sutures in an interrupted simple fashion.The upper half of these were placed and tied down and the lower half were then placed after the rest of the seprafilm was placed.The subcutaneous tissue was irrigated out with antibiotic solution, and the skin was reapproximated using interrupted 3-0 nylon vertical mattress sutures.Skin was closed with skin staples.Sterile dressings using tegaderm were applied.I then matured the colostomy.There was too much fatty tissue to do the usual everting colostomy that i choose to do, so i simply put a number of sutures in there knowing that some of the fatty tissue will reabsorb.We had cleaned as much of the fatty tissue on the colon as we thought was safe without endangering his blood supply.Stoma bag was then applied.The patient was transported back to recovery in good condition.He may have trouble with pain control initially.I will probably watch him in intensive care.We will be starting tpn on him as he has not eaten well the better part of 10-12 days.¿ ¿ (b)(6) 2011: (b)(6) medical health system.Intraoperative record.Asa: 3e.Implant record.Seprafilm x2.Manufacturer: genzyme biosurgery.¿ (b)(6) 2011: (b)(6) medical health system.(b)(6), md.Discharge summary.Had a 1 to 1 ½ week history of intermittent, sharp, stabbing pain in left lower quadrant.Had not vomited, had been nauseated, last bowel movement was a week prior, hurt to urinate.Had low-grade fever, went to hospital and ct abdomen showed left lower quadrant peri-colonic abscess along with diverticula in sigmoid colon thought to represent a diverticular abscess from perforated diverticulitis.Had a ventral hernia repair that was unrelated 3 weeks prior; incision was doing well.Medical history positive for reflux, hypertension, possible leaky heart valve, ventral hernia repair, appendectomy, smoker.Abdominal exam showed soft, nondistended abdomen, tender in left lower quadrant.No hernias noted.Incision from previous surgery healing well.White count was 16,100.Impression was that of left lower quadrant pain secondary to perforated diverticulitis.Placed on zosyn, pain medications.The following day, (b)(6) 2011, he complained of worse pain.Had not had any stool.Abdomen was not distended.Ct directed abscess drainage done successfully.Continued on intravenous antibiotics, placed on full liquids.By(b)(6) 2011, feeling a bit better and white count down to 11,100.Started gentle 2-day bowel prep and underwent surgery on 6/13/11 where he had excision of inflamed segment of sigmoid colon with primary anastomosis done with stapling from below.Did have some adhesions from previous appendicitis.Postoperatively, came along quite nicely.By third postoperative day, passing gas and stool, no nausea/vomiting, abdomen less tender; increased diet.Thought he could possibly go home (b)(6) 2011; however, on (b)(6) 2011, he had chicken tenders, 2 pepsi¿s and felt bad abdominal pain.Spiked fever to 101.2.Passed bowel movement and gas; felt a bit better.White count had risen to 17,200.Held discharge.Still tender in lower abdomen, but without guarding; white count increased to 21.5.Temperature max about 100.Stopped zosyn, started tygacil.On (b)(6) 2011, had gastrografin enema, which showed small leak.Underwent exploration of anastomosis, in spite of the fact it had 2 very adequate doughnuts and no tension to it, came apart fairly easily with minimal dissection.Distal bowel was oversewn, it should be remembered that he had an end-to-side anastomosis where bowel has been closed.It is at the site of the rectal stump.Kept in icu overnight, (b)(6) 2011.Postoperative day 1, seemed to be doing better.Kept on total parenteral nutrition.By (b)(6) 2011, passing gas, temperature max 99.1; it was thought sepsis was improving, ileus resolving.Started sips of clear liquids, discontinued foley, gave albumin.Ileus fairly slow to resolve.Began having ostomy output.By (b)(6) 2011, feeling much better, positive stool and gas output, stoma okay.White count 19,700.Discontinued total parenteral nutrition, increased diet, white count came down a little.Thought that around postoperative day 10 from second operation, he could probably be discharged on augmentin.Discontinued central line, took out half of his staples and his drain.Instructed to be seen in office (b)(6) 2011.Final diagnoses: perforated diverticulitis with abscess, responded well to percutaneous drainage and intravenous antibiotics with subsequent sigmoid colon resection from which he developed leak and had to have diversion via colostomy with oversewing the distal anastomotic site.Sepsis, secondary to colon leak.Hypertension.Gastroesophageal reflux disease history.¿ (b)(6) 2012: (b)(6) medical center.(b)(6), md.Procedure report.Preoperative diagnosis: gastrointestinal hemorrhage, site unknown, blood from ostomy.Complex history of multiple surgeries after a hernia repair operation, reported distal colectomy secondary to diverticulitis, with revision, outlying hospital procedures.Postoperative diagnosis: normal ostomy os with stool.Stool throughout postoperative colon.Operation: colonoscopy per ostomy to hepatic flexure, aborted early secondary to colon packed full of stool.Complications: no immediate complications before, during, or after the procedure.Impression: colon full of solid stool, making this exam essentially worthless.There was no evidence of active or recent gastrointestinal hemorrhage on this study.¿ (b)(6) 2012: (b)(6) medical center.(b)(6), md; (b)(6).History and physical.Ventral hernia repair with ventralex mesh (b)(6) 2011.The following month, suffered bout of diverticulitis with perforation.Peri-colonic abscess initially drained, then sigmoidectomy performed; anastomosis leaked and required colostomy with hartmann¿s.Has been evaluated in clinic by dr.Terhune for colostomy reversal.Nicotine test at that time negative.Since visit, has been in good health, no recent infectious symptoms.Colostomy functioning well but has some dull pain around stoma.Smoked 1.5 packs/day; quit 1 month ago.Wt.265 [lbs.] exam: abdomen soft, obese, nondistended, nontender, midline laparotomy scar, ostomy with mild tenderness to palpation medially.Impression/plan: colostomy.Will undergo colostomy takedown with flex hd bridge and ventral hernia repair.Addendum: change in plan that i discussed extensively in clinic is we will plan ostomy takedown, possible diverting ileostomy and plan a staged hernia repair of stoppa type.As such, will employ an absorbable mesh.He knows there is close to 100% chance of return of his hernia.Main goal today is takedown of ostomy.We would plan on next staged operation (ileostomy takedown or hernia repair, depending on what we do today), several months from now.Has quit smoking for almost 4 months now.Implant procedure: cystoscopy with placement of bilateral ureteral stents.Flexible sigmoidoscopy.Exploratory laparotomy with lysis of adhesions taking approximately 1.5 hours.Reversal of end colostomy with 28 eea stapler for colocolostomy anastomosis.Abdominal wall closure with bio-a tissue reinforcement.Implant: gore® bio-a® tissue reinforcement [fs2020/8419258, 20 x 20 cm] implant date: (b)(6), 2012 (hospitalization (b)(6), 2012) ¿ (b)(6) 2012: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: diverticulitis with colostomy, now undergoing colostomy takedown.Resident assistant: (b)(6), md.Anesthesia: general.Indication: (b)(6) is a 34-year-old male with a history of diverticulitis having undergone a prior colostomy.I have been asked to place ureteral stents for intraoperative identification of the ureters.The risks, benefits, and alternatives have been explained.Findings at the time of the operation: within the bladder itself there were no stones, tumors, or diverticuli.The bilateral whistle tip catheters were placed at the right and left ureters without complication.Condition was stable throughout and blood loss was minimal.Overlapping statement: of note, this case did partially overlap with the second surgery.I was present for all key/critical parts and scope insertion to removal and further intraoperative stent placement.Dr.Nicole miller was the immediately available as a covering physician for nonessential overlap.Procedure in detail: ¿mr.Jerry thrasher was taken to operating room #30 of the main or.After identification, induction of excellent general endotracheal anesthesia, a sterilely prepped and draped in the dorsal lithotomy position.The time-out was performed and confirmed all key elements.A #21-french cystoscopy was passed per urethra without difficulty into the bladder.He did have somewhat of a high median lobe.Within the bladder itself, there were no stones, tumors, or diverticuli.Open-ended whistle tip catheters were then placed first of the right side to about 25 cm and then up the left side both passed easily.After completion, the scope was removed securing the ureteral catheters to a foley catheter.Counts were correct.Complications none and condition was stable throughout.Of note, the case partially overlapped the second surgery.I was present for all key/critical parts and dr.(b)(6) was the available the covering physician for nonessential overlap.¿.
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Updated health effect.Updated investigation finding.Updated type of investigation.Updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.No further investigation is required at this time.Through gore's investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as false claim and no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® bio-a® tissue reinforcement instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use states: ¿the implanted gore® bio-a® tissue reinforcement is a porous fibrous structure composed solely of synthetic bioabsorbable poly(glycolide: trimethylene carbonate) copolymer.Degraded via a combination of hydrolytic and enzymatic pathways, the copolymer has been found to be both biocompatible and nonantigenic.In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months.¿ therefore, this gore device would not be expected to contribute to infection, hernia recurrence and explant, beyond this timeframe.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without bio-a.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, migration, contraction, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device was not available for evaluation.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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