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Model Number GKFC12
Device Problem Insufficient Information (3190)
Patient Problem Adhesion(s) (1695)
Event Date 10/30/2020
Event Type  Injury  
Manufacturer Narrative
Added medical history. Conclusion code remains unchanged. 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) 2016: not indicated. (b)(6), md. Discharge summary. Discharge diagnosis: diverticular bleed, colitis, anemia due to gi bleed. Hospital course: admitted for likely lower gastrointestinal bleeding. Reports normal egd and colonoscopy (b)(6) 2016. Rbc nuclear scan showed no evidence of acute gastrointestinal bleeding. (b)(6): status post colonoscopy; bleeding from inner portion of tiny diverticulum at 57 cm from the anal verge. Hemostasis achieved after a few rounds of bipolar electrocoagulation were done and the diverticulum was then closed with two boston scientific resolution clips. The area was tattooed with 0. 5 ml of ink spot. Discharged once the hemoglobin was stable and she was doing well clinically. On (b)(6) 2016: (b)(6) medical center. (b)(6), md. Operative report. Pre-procedure diagnosis: uterine prolapse, cystocele, rectocele. Post-procedure diagnosis: same. Procedures: tvh [total vaginal hysterectomy]/bso [bilateral salpingo-oophorectomy], a&p [anterior and posterior] repair, cystoscopy. Assistant: (b)(6). Anesthesia: general anesthesia, (b)(6), crna [certified registered nurse anesthetist]. Findings: ¿grade 3 uterine prolapse, cystocele; grade 2 rectocele. ¿ complications: none. Estimated blood loss in ml¿s: 50. Specimens: uterus, bilateral tubes & ovaries. Implant: acell graft. Disposition: pacu. On (b)(6) 2016: (b)(6) medical center. Implant record. Graft st tis 10x7cm, pfm0710. On (b)(6) 2017: (b)(6) medical center. (b)(6). Nurse notes. History of bone cancer 2004 treated with chemo x 8 months. On (b)(6) 2017: (b)(6) medical center. (b)(6). Operative report. Procedure: anterior colporrhaphy with acell and skin tag removal. Preoperative diagnoses: grade iii cystocele and left inner thigh skin tag. Postoperative diagnoses: grade iii cystocele and left inner thigh skin tag. On (b)(6) 2018: (b)(6) medical center. (b)(6). Operative report. Procedure: colonoscopy. Preoperative diagnosis: rectal bleeding. Postoperative diagnosis: severe sigmoid diverticulosis. On (b)(6) 2018: (b)(6) medical center. (b)(6), rn. Nurses notes. Procedure: davinci left colectomy. Asa 2. On (b)(6) 2018: (b)(6) medical center. (b)(6). Operative report. Procedure: da vinci left colectomy converted to open with low pelvic anastomosis-cdh #29. Mobilization of splenic flexure. Vascular assessment with icg. Preoperative diagnoses: gastrointestinal bleeding of the left colon. Extensive diverticulosis. Postoperative diagnoses: gastrointestinal bleeding of the left colon. Extensive diverticulosis. Assistant: (b)(6), lsa. Anesthesia: general endotracheal. Indications: (b)(6) woman has been hospitalized 4 times in the last couple of years with significant gastrointestinal bleeding. Previous studies including recent colonoscopy of localized bleeding of left colon. Surgical therapy was recommended and accepted. Findings: 1. In general, there is extensive diverticular change of sigmoid colon and multiple adhesions due to previous surgical procedures. 2. Extensive adhesions in right upper quadrant due to previous surgery. 3. Has undergone a prior umbilical hernia repair and there is retained mesh with adhesions to the mesh prosthesis. Description of procedure: ¿after obtaining informed consent, the patient was taken to the operating room and administered general endotracheal anesthesia. She was placed in lithotomy position and the abdomen and perineum were prepped and draped in usual sterile fashion. The abdomen was entered using a visiport trocar to the right of the umbilicus. Pneumoperitoneum was obtained. Additional trocars were placed in the right lower quadrant, upper midline, and in the left upper quadrant. Using laparoscopic technique. I was able to take the adhesions down from the previous hernia repair. This exposed the mesh prosthesis. The omentum was then reflected into the upper abdomen. An assistant port was placed in the right flank. The patient was then placed in a head down, right side down position. The da vinci robot was then docked. The small bowel adhesions were divided with sharp scissors and the small bowel was mobilized up out of the pelvis. Adhesions of the sigmoid colon to the pelvis were divided with scissors and ultimately entire sigmoid colon is free. The medial aspect of the sigmoid colon mesentery was incised, and the inferior mesenteric artery was exposed. This was divided with a vascular stapler. Retroperitoneal dissection was accomplished exposing the left ureter, which was preserved. Dissection continued to the level of the inferior mesenteric vein, which was not taken at this time. Further retroperitoneal dissection was accomplished. The lateral peritoneal attachments were taken down and dissection into the pelvis was performed. The appropriate distal margin of resection on the upper rectum was chosen. This area was cleared of fatty and vascular tissue. The bowel was transected with 2 applications of the linear stapler. The gastroenterologists caution that the disease on the left side was significant and encouraged a standard left colectomy. I then proceeded with mobilization of splenic flexure to perform the extended surgery was requested. Omental attachments were taken down with the vessel sealer. In stepwise fashion, complete mobilization of the splenic flexure was accomplished. The inferior mesenteric vein was isolated, and this was transected with a vascular stapler. We then chose the appropriate proximal margin of resection. I then noticed there was significant bleeding in the left upper quadrant. Despite best attempts at visualization, i was just not able to identify the exact bleeding source and decided to convert the procedure to open. The da vinci robot was then undocked. All the trocars are removed, and midline incision was used to enter the abdominal cavity. I was ultimately able to identify the bleeding site as a small vessel on the underside of the pancreas. This controlled with a several suture ligatures. The abdomen was then irrigated copiously with saline. Evicel is placed over the site. The area was watched of an extended period of time and there was no further evidence of bleeding. I decided to proceed with this resection. The proximal margin of resection was isolated and cleared of fatty and vascular tissue. There is severe diverticular change but was ultimately able to find a satisfactory area for the proximal margin of resection. The purse string clamp was applied. The bowel transected. Instillation of icg and use of the da vinci camera allowed us to prove excellent vascularity to this portion of the colon as well as rectal stump. We then proceeded with the end-to-end anastomosis using the cdh 29 stapler. Air insufflation and inspection of the anastomotic rings confirms anastomotic integrity. The remaining evicel was placed on the __ anastomosis. The small bowel was briefly evaluated in its entirety. Omentum is placed in the left abdomen in the region of the pancreas. I decided to remove the piece of old mesh that we had divided when opening. This was excised with electrocautery. The fascial edges were identified, and abdominal fascia was reapproximated with interrupted #1 pds suture. The subcutaneous tissue was irrigated copiously with saline. The skin was reapproximated with skin staples and dressings were applied. The patient was then awakened from anesthesia having tolerated the procedure well. ¿ on (b)(6) 2018: (b)(6) medical center. (b)(6). Discharge summary. Admission date: (b)(6) 2018. Discharge diagnosis: diverticular bleed status post left colectomy with anastomosis (b)(6). Hospital course: admitted for diverticular bleed. Consulted gi who agreed to monitor clinically without acute intervention. Hgb dropped to below 7 the next day and required one-unit prbc transfusion. Hgb remained stable and ready to be discharged home, however on day of discharge patient had numerous bloody bowel movements and thus was kept in hospital for close monitoring. Bleeding did not resolve and subsequently needed total of 4 units of prbc and general surgery consulted for davinci left colectomy. While in surgery operation was converted to open. Post op was on aggressive pain control with diet slowly advanced. Eventually regained bowel function and ambulating, tolerating diet. Pain well controlled. Ready to be discharged home at that point. Instructions: discharge home, activity as tolerated, diet advance as tolerated. Follow up with dr. (b)(6) in office for staple removal. Follow up with dr. (b)(6) next week for lab studies. On (b)(6) 2018: (b)(6) medical center. Radiology-ct abdomen, pelvis w/contrast. Indication: abdominal pain. Impression: small bowel obstruction pattern transitional level right upper quadrant just medial to liver edge tip. On (b)(6) 2018: (b)(6) medical center. (b)(6). Discharge summary. Admission date: (b)(6) 2018. Discharge diagnosis: partial sbo. History of asthma, normocytic anemia, hypertension, tia, anxiety, depression, urinary incontinence, restless leg syndrome, iron deficiency, h. Pylori, gastroesophageal reflux disease, diverticulosis status post left hemicolectomy (b)(6) 2018. Hospital course: presents with abdominal pain that started last night. Pain is located diffusely around the umbilicus and is on and off for about a week but last night it was worse 10/10. Pain comes and goes, not related to food intake. Had multiple abdominal surgeries including the recently left hemicolectomy on (b)(6) 2018 by (b)(6) due to severe bleeding diverticulosis. Instructions: discharge home, activity as tolerated, follow up pcp in 1-2 weeks, advance diet slowly. Follow up with surgery in 2 weeks. Implant procedure #1: exploratory laparotomy for distal small bowel obstruction, ileal and omental adhesiolysis, enterorrhaphy x1, large incisional herniorrhaphy with prefascial bard sinacore 12 cm round biologic mesh. Implant: gore® synecor intraperitoneal biomaterial [gkfc12/18210889, 12 cm circular]. Implant #1 date: (b)(6) 2018 (hospitalization (b)(6) 2018). On (b)(6) 2018: (b)(6) medical center. (b)(6). Operative report. Preoperative diagnoses: small bowel obstruction secondary to incarcerated incisional hernia, 8 cm round fascial defect. Postoperative diagnoses: small bowel obstruction secondary to incarcerated incisional hernia, 8 cm round fascial defect with dense ileal adhesions of 3 loops of bowel to the right lateral fascial edge. Assistant: (b)(6), pa. Anesthesia: general endotracheal, dr. (b)(6). Estimated blood loss: 20 ml. Findings: large septated incisional hernia with obstructed ileal loops fixed the fascial edge and hernia defect with incarcerated omentum. Ileum unable to dissect free without enterotomy. Hernia sac removed from subcutaneous and prefascial biologic mesh fixed at mesh edge and fascial edge with sutures. Technique: ¿ms. (b)(6) was taken to the operating suite and placed in supine position under general endotracheal anesthesia. The patient¿s abdomen was prepped and draped in usual fashion. Ioban steri-drape was used. The previous midline scar was excised down to fascia exposing 2 areas of herniation, one immediately around the umbilicus and one immediately above the umbilicus separated by a small fascial connection. This fascial connection was divided and the large hernial defect was exposed. The hernia sac was entered. The bowel was fixed to the fascial edge along the lateral aspect, and this was dense adhesion of small bowel to the fascial edge and hernia sac. Care was taken to very carefully dissect the small bowel free hoping not to injure the small bowel since we had planned to perform a hernia repair with mesh and the bowel was dissected free completely without entry at this point. The hernia sac was then resected from the subcutaneous and submitted to pathology for permanent section. The hernial defect measured approximately 8 to 10 cm in diameter. A large hernia sac was involving subcutaneous all the way up to the skin. The patient is relatively obese. Once the small bowel was replaced into the peritoneum and within the abdominal wall confine the small bowel was replaced into the peritoneum and within the abdominal wall confine the small bowel was then carefully traced from the ileocecal valve to the ligament of treitz. In doing so, there were 3 areas of mid ileum that had been involved with the hernia sac. Each of these 3 had serosal defects that were chronically scarred, and these were opened up and closed transversely used interrupted 3-0 silk and one occasion 3-0 vicryl lembert sutures. Once this was completed, there was one other that was evaluated, and it did appear to be entering the mucosa and the defect was probably a centimeter in greatest dimension. The edges were debrided, and the mucosa and muscular wall were inverted then 3-0 vicryl simple suture followed by 3-0 gi silk lembert sutures on the seromuscular layer. Once this was completed the entire small bowel again was ran. The peritoneum was irrigated with copious saline. There were some remnants of omentum that had been left from the previous surgery that were bleeding. These were serially ligated with 3-0 vicryl suture ligatures and resected and submitted to pathology. At this point, again probably 2 to 3 l of saline was used to serially dilute the peritoneal contents and control any hemorrhage that was present after which a 12-cm round bard sinacore biologic mesh was placed prefascial. The perimeter of the mesh was fixed to the endoabdominal fascia circumferentially at 6 points. Once the mesh was in place the fascial edge was also fixed to the mesh using interrupted 0 prolene sutures as well. Once this was completed, the 19-french blake drain was placed through a right lateral stab wound in the skin and directed into the subcutaneous defect. The subcutaneous tissue was approximated using interrupted 3-0 vicryl sutures to eliminate any dead space and the dermis was also closed with the same. The skin was closed with approximating staples. The patient returned to the recovery room after a sterile dressing was placed on the abdominal wall using 4 x 4¿s, and tegaderm. Abdominal binder was placed as well. Estimated blood loss 20 ml. Sponge, needle, and instrument count correct x2. ¿ no complications. Pathology: omentum, hernia sac, skin scar, and subcutaneous. Drains: suprafascial 19-french blake placed through a right lateral abdominal stab wound. On (b)(6) 2018: (b)(6) medical center. (b)(6). Implant record. Gore® synecor intraperitoneal biomaterial 12cm circular. Cat #: gkfc12. Serial (b)(4). Quantity: 1. Implant location: abdomen. Manufacturer: w. L. Gore & associates, inc. The records confirm a gore® synecor intraperitoneal biomaterial (gkfc12/18210889) was implanted during the procedure. Relevant medical information: on (b)(6) 2018: (b)(6) medical center. (b)(6). Surgical case record. Procedure: exploratory laparotomy for bowel obstruction, possible repair of incisional hernia with mesh. Anesthesia: general, asa 3. On (b)(6) 2018: (b)(6) medical center. (b)(6). Discharge summary. Admission date: (b)(6) 2018. Discharge diagnosis: incarcerated periumbilical abdominal wall hernias, partial sbo, history postoperative fever. Hospital course: presenting with acute abdominal pain, nausea, vomiting. Abdominal pain was periumbilical, crampy, intermittent progressed to constant, severe 10/10, multiple episodes of bilious vomiting. Ct abdomen showing multiple incarcerated abdominal wall hernias with sbo. Surgery consulted and patient underwent ex lap with enterorrhaphy and incisional hernia repair with mesh with dr. (b)(6) on (b)(6)2018 and managed with 4 days of zosyn. Postop course complicated by post op day 1 attributed to atelectasis, managed with encouraged use of incentive spirometer. Remainder of hospital course unremarkable. Patient discharged home. On (b)(6) 2019: (b)(6) medical center. (b)(6). Operative report. Preoperative diagnosis: prolapse of the vaginal vault post-hysterectomy. Postoperative diagnosis: prolapse of the vaginal vault post-hysterectomy. Surgeon: (b)(6). Assistant: (b)(6), certified surgical assist. Anesthesia: general anesthesia, crna (b)(6). Estimated blood loss: 200 ml. Procedure: posterior repair, anterior repair, sacrospinous ligament fixation, perineoplasty, sling and cystoscopy. Findings: vault prolapse with a tight introitus. Description of procedure: ¿under general, the patient cleansed and draped in dorsal lithotomy. Exam under anesthesia performed identifying a vault prolapse. Texas lone star instrument placed for retraction. Anterior vaginal wall cuff dimples identified and tagged with suture. Then, we proceeded to infiltrate anterior vaginal wall with lidocaine, opened in the midline. Vesical vaginal fascia plicated in the midline with multiple sutures of 0 vicryl in 3 rows correcting the cystocele. Then, we proceeded to identify the mid urethra. It was infiltrated with lidocaine, opened in the midline, and vaginal space dissected to the ischiopubic rami bilaterally. Stab incisions made at the level of the thigh fold at the level of the clitoris. Proprietary needle of the obtryx passed from the skin around the bone into the vaginal wall. Needle and mesh attached; mesh passed from the vaginal area around the bone to the skin. Care was taken not to pit hole the vaginal wall. Procedure repeated in identical manner on the contralateral side. Cystoscopy performed verifying the integrity of the bladder and urethra. No injury, no mesh. Two jet flows from each ureteral orifice. Final positioning of the mesh done using curved mayo¿s between the mesh and the vaginal mucosa. Excess plastic suture and mesh cut at the level of the skin and mesh placed in a tension-free manner on the mid urethra. Vaginal wall closed from the sling and the anterior repair. Then, we proceeded to open the posterior compartment. The perirectal space entered, spine and sacrospinous ligament identified. Sutures placed on the sacrospinous ligament bilateral. Posterior repair rectocele reduced with multiple sutures in 3 rows of 0 vicryl interrupted. Scar tissue in the perineum cut and perineum closed again giving an extra 1 cm to the introitus. Sacrospinous ligaments closed and fixated from the posterior and the anterior fascia bringing the vaginal tissue away in cephalad and posterior in the pelvis. Vaginal wall closed. Packing in place. The patient tolerated the procedure well and was transferred to recovery room awake and stable. ¿ on (b)(6) 2020: (b)(6) medical center. (b)(6). Discharge summary. Discharge diagnosis: lower gi bleed, normocytic anemia, history diverticulitis status post hemicolectomy in 2018. Hypertension stable, insomnia, history breast cancer, mantle cell lymphoma, obesity, hypokalemia. Hospital course: (b)(6) female to bamc ed with complaints of bloody bowel movements. Associated with lower abdominal pain, located mostly in suprapubic region, non-radiating. Has had similar episode in 2018 when diagnosed with diverticulitis and had left hemicolectomy done. Gastroenterology consulted and recommended no colonoscopy since she didn¿t have new episodes of bleeding and hgb and hct was stable. Her serial hgb and hct was monitored and didn¿t have new episodes of lower gi bleed. Clinically stable to be discharged home. (b)(6). Bmi 32. 1 [calculated]. Instructions: follow up with primary care physician in 3-5 days. Follow up with gi in 2-4 weeks. Explant procedure: repair of recurrent incarcerated ventral hernia with mesh. Bilateral component separation. Small bowel resection with primary anastomosis. Removal of necrotic mesh. Excision of skin and subcutaneous tissue, 40 square cm. Explant date: (b)(6) 2020 [hospitalization ni [not indicated]] on (b)(6) 2020: (b)(6). Operative report. Preoperative diagnosis: recurrent incarcerated ventral hernia. Postoperative diagnosis: recurrent incarcerated ventral hernia. Anesthesia: general. Indication: the patient is a pleasant (b)(6) female who had a history of a partial colon resection and subsequent ventral herniorrhaphy, who had developed recurrence in 2 subsequent ventral herniorrhaphy, who had developed recurrence in 2 separate areas. This was symptomatic and enlarging. We opted to proceed with repair utilizing mesh and bilateral component separation. She was counseled and consented. Description of procedure: ¿she was taken to the operating room after adequate induction of general anesthesia. Her abdomen was prepped and draped in standard sterile surgical fashion. Perioperative dose of antibiotics was administered scds in place, timeout was performed. I began my operation by making a midline incision, carried down through layers of the abdominal wall, at which point i encountered eventration of the abdominal wall with attenuation of fascia and mesh as well as diastasis of the rectus musculature with loss of domain. I was able to eventually work my way through the mesh into the peritoneal cavity. I encountered extensive adhesions. More cephalad portion of this mesh was adherent to the large bowel that was easily taken down with judicious sharp dissection. Very small deserosalization was addressed with silk in a lembert fashion. Inferiorly, there was an area of small bowel that was densely adherent to mesh. I opted to work my way circumferentially. More caudad to this, there was an additional hernia just to the left of midline. I was able to enter this hernia after reducing the contents from peritoneal direction and eventually encircled a portion of necrotic mesh that was adherent to 2 separate loops of small bowel. This mesh was excised, and it was evident that the small bowel was densely adherent to the point that i would not be able to free it without incurring multiple full thickness injuries. I opted therefore to proceed with small bowel resection. I created defects in the mesentery proximally and distally, came across that with blue load gia stapler, took the mesentery in a stepwise fashion with gray load gi stapler, passed it off the table as specimen. Prior to changing gloves, i proceeded with side-to-side functional end-to-end anastomosis by cutting the corners of the limbs of small bowel and firing down the lumens to create a common lumen. Confirmed it was of adequate caliber and hemostatic. I then reapproximated the crotch with silk. I oversewed the open end with running locking monofilament suture and oversewed with silk in a lembert fashion. I tested to make sure there it was pressure tight and of adequate caliber with finger inspection. I then reapproximated the mesenteric defect with silks. I placed 4 ml of tisseel across all staple and suture lines to include the area that was repaired on the colon. I confirmed correct needle and sponge counts. I made sure i had no additional adhesions along the posterior peritoneum. There was a loss of domain. I opted therefore to proceed with creation of myocutaneous flaps bilaterally, doing my best to keep as many perforators as possible. Planes were quite disrupted, but i was able to eventually work my way to the midaxillary lines bilaterally, to the pubis inferiorly, to the xiphoid and in fact anterior to the chest wall superolaterally. At this point, the fascia was reapproximated along the midline. I made sure that i excised the fascia that was between the 2 previously mentioned hernias. The fascial edges were cleaned with cautery. I then used a 20 x 15 cm piece of biologic mesh, strattice, and secured it circumferentially with monofilament suture at 3 cm intervals. I made sure that this was tension free. I confirmed correct needle and sponge counts on 2 occasions. / i reapproximated the fascia with running looped pds suture in a locking fashion. Minimal tension along the cephalad portion but the remainder was tension free. It came together nicely. I then placed two 15 blake drains level with nylon sutures. Base of the umbilicus was reapproximate at the fascia with vicryl. I then excised 40 square cm of skin and subcutaneous tissue of the wound edges in order to have good margins for skin closure. That was then closed with vicryl and skin clips. She tolerated the procedure well. There were no apparent intraprocedural complications. Plan is to admit the patient and await return of bowel function. ¿ estimated blood loss: 100 ml. Pathology: skin and subcutaneous tissue to pathology, small bowel, and mesh to pathology. On (b)(6) 2020: (b)(6). Implant record. Implant: msh ptch hrnia xl 22. 1 x 27. 1 cm davol. Comment: not used. Relevant medical information: on (b)(6) 2020: (b)(6). Pathology report. Specimen: (b)(6). Subm (b)(6) md. Clinical information: ventral hernia. Tissues: small intestine, nos (small intestine, skin, subcut). Final diagnosis: small bowel with surface adhesions and suture material. Small bowel mucosa with no significant pathology. Focal fat necrosis. No malignancy seen. Hernia sac with no acute inflammation or malignancy seen. Source description: small intestine, skin, subcutaneous tissue. Gross description: the case is received in one formalin container labeled with the patient¿s name and source. The specimen is designated ¿small intestine, skin, subcutaneous tissue¿ and consists of three separate pieces of soft tissue. The first portion is an unoriented segment of small bowel (25 cm in length by 3 cm in diameter), with attached yellow, lobulated mesenteric fat. Near both ends of the small bowel there is red-brown fibro membranous tissue adhered to the serosa with embedded white-tan synthetic mesh, and measures 7 x 5 x 0. 8 cm and 6 x 3 x 0. 5 cm. This area of adhered soft tissue is located 1 cm from the closest stapled resection margin. Both margins are grossly viable. The small bowel is opened to reveal pink-tan, grossly unremarkable mucosa. The underlying white-tan wall measures 0. 1 cm in thickness. There are no perforations identified grossly. The mesenteric fat displays focal hemorrhage at the area of adhered soft tissue and mesh. Additionally, within the same container are two pieces of yellow, lobulated soft tissue with pink-red irregular fibro membranous tissue, measuring 8 x 7 x 2 cm in aggregate. There are no discrete masses or lesions identified grossly. Representative sections are submitted in three blocks, as follows: a1: bilateral small bowel resection margins, shaved; a2: representative small bowel with adhered soft tissue and mesh; a3: representative discolored fat. A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.   it should be noted that the gore® synecor intraperitoneal biomaterial instructions for use 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 gore® synecor intraperitoneal biomaterial instructions for use also states: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material.
Event Description
It was reported to gore that the patient underwent laparoscopic incarcerated incisional hernia repair on (b)(6) 2018 whereby a gore® synecor® intraperitoneal biomaterial was implanted. The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: additional surgery, adhesions, bowel resection, hernia recurrence, pain, mesh removal. Additional event specific information was not provided.
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Manufacturer (Section D)
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
MDR Report Key12691723
MDR Text Key282493833
Report Number3003910212-2021-01306
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/15/2021
Device Model NumberGKFC12
Device Catalogue NumberGKFC12
Was Device Available for Evaluation? No
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/25/2021 Patient Sequence Number: 1