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(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: the journal of minimally invasive gynecology vol 29, no 9, september 2022.Https://doi.Org/10.1016/j.Jmig.2022.05.009.
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Title: natural orifice specimen extraction colorectal resection for deep endometriosis: a (b)(4) case series.This retrospective study aims to present our experience with the use of the natural orifice specimen extraction (nose) technique for segmental bowel resections in cases of colorectal endometriosis.Between (b)(6) 2021 (when the approach was first adopted) and (b)(6) 2021, all patients managed by natural orifice specimen extraction (nose) colectomy for colorectal endometriosis were collected and identified.50 patients were identified fitting our search criteria, and all were included in the study.During surgery, the mesorectum and mesosigmoid was opened in close proximity with the bowel wall, in an attempt to minimize denervation of the corresponding bowel segment.In laparoscopic cases, this step was performed with the use of a vessel- sealing device (harmonic scalpel ace, ethicon endo- surgery, cincinnati, oh).In cases of opening the vagina as part of a concomitant surgical procedure, the anvil of the circular stapler (covidien eea circular stapler with tri-staple technology 28/33 mm, minneapolis, mn) was inserted through the vagina.A transverse colotomy above the upper limit of the bowel nodule was performed using the harmonic scalpel ace or monopolar scissors to allow insertion of the anvil in the bowel lumen.The anvil was sutured in place laparoscopically with a monofilament suture (pds 2.0, ethicon inc, cincinnati, oh).Reported complications included for pds 2.0, : 4 cases of clavien-dindo iiib complications in our series : (1) a case of anastomotic leak.The patient presented on postoperative day 5 with raised inflammatory markers (c-reactive protein of 280 mg/l), abdominal pain, and vomiting.A computed tomography scan identified a postoperative ileus with significant pneumoperitoneum and a 19 £ 13 mm area suspicious of pelvic collection, close to the anastomosis.The patient returned to theater on the same day.A laparoscopy and blue-dye test per rectum identified moderate amount of fecaloid material in the pelvis and a dehiscence on the posterior aspect of the anastomosis.Copious lavage of the pelvis with saline was performed, together with left terminal colostomy and a drain was left in situ.The patient¿s postoperative course was further complicated by sepsis and necessitated 2 further surgical interventions for drainage of pelvic collections on days 13 and 20 after the initial operation.The patient¿s condition, then, markedly improved, and the patient was discharged home with a view to reverse the colostomy in 8 months.(1) postoperative bowel obstruction.On day 3 postoperatively, the patient presented with typical signs and symptoms of intestinal obstruction.An urgent midline, subumbilical laparotomy revealed an obstruction at the level of the ileum.A loop ileostomy was performed and a drain was left in the pelvis.The patient¿s condition markedly improved and was discharged home on day 10.A reversal of the ileostomy was planned 3 months after the midline laparotomy.(2) a total of 2 patients required a return to theater in view of probable pelvic collections (no macroscopic evidence of pus): the first patient on n postoperative day 3, the patient developed postoperative ileus and imaging suggested a probable pelvic collection.Repeat laparoscopy on day 4 revealed a dilated small bowel with no evidence of fistula or anastomotic complications.The pelvis was washed thoroughly and a drain left in situ.Bacteriologic examination of the collected fluid was positive for serratia marcescens.The patient was discharged on postoperative day 5 and the ileostomy was reversed 2 months after the initial procedure.The second patient presented with raised inflammatory markers and radiological evidence of probable pelvic collection (completely asymptomatic) on day 7 after transanal nose.Left parametrectomy, treatment to left ovarian endometrioma, vaginectomy, appendicectomy, and application of permacol surgical implant (covidien, minneapolis, mn) to separate vaginal and rectal sutures.Repeat laparoscopy identified a collection between the left ovary and the uterus with signs of localized peritonitis.The collection was drained and a drain left in situ.The collected fluid culture was positive for escherichia coli.The patient was discharged on postoperative day 4.It is worth noting that, in both cases, there was no macroscopic evidence of pus collected in the pelvis.Reported complications included for harmonic scalpel ace : 1 case of clavien-dindo iiib complications in our series : (1) third patient required a return to theater on postoperative day 1 to arrest bleeding from the mesorectum.Repeat laparoscopy revealed a hemoperitoneum of 800 ml with multiple small bleeding points on the mesorectum.These were coagulated and a drain was left in the pelvis.The patient required 2 iron infusions and was discharged home on postoperative day 5.It was concluded , that natural orifice specimen extraction (nose) colectomy is a reproducible surgical technique for the management of colorectal endometriosis.The complication rate appears comparable with the conventional (minilaparotomy) surgical approach.In experienced hands, this technique has a short learning curve, both in laparoscopy and in robotic surgery.
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