MAUDE Adverse Event Report: ETHICON INC. NYLON TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE.

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Fistula (1862); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products (vicryl suture, nylon tape and pds suture) involved caused and/or contributed to post-op complications (wound infection, biochemical leaks, grade b pancreatic fistula, grade c pancreatic fistula and delayed intra-abdominal bleeding, grade a delayed gastric emptying, biliary fistula with biloma formation bilio-enteric anastomotic stricture) described in the article? please specify.Does the surgeon believe there was any deficiency with the ethicon products (vicryl suture, nylon tape and pds suture) used in this study? if yes, please provide patient demographics for the patients that experienced the post-operative complications (wound infection, biochemical leaks, grade b pancreatic fistula, grade c pancreatic fistula and delayed intra-abdominal bleeding, grade a delayed gastric emptying, biliary fistula with biloma formation bilio-enteric anastomotic stricture)? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: journal of robotic surgery (2020) 14:493¿502.Https://doi.Org/10.1007/s11701-019-01018-w.Events were submitted via 2210968-2021-09445 and 2210968-2021-09446.

Event Description

Title: robotic-assisted versus open pancreaticoduodenectomy: the results of a case-matched comparison.The aim of this study is to investigate and analyze the safety and feasibility of the robotic approach for pancreaticoduodenal resections for cancer, performing a 1:1 casematched comparison of 35 patients who underwent robotic pd and 35 patients who underwent open pancreaticoduodenectomy (opd).From august 2014 to april 2016, a total of 35 patients who underwent rpd for cancer were collected via our prospectively maintained database and enrolled in the study.Further 35 patients who underwent opd in the same study period were selected and matched in a case¿control study at a ratio of 1:1 according to age, sex, body mass index (bmi), american society of anesthesiologists (asa) score, tumor size and location.The distal stomach is divided with a blue load 75-mm cartridge laparoscopic stapler (ethicon).The pancreas is encircled using a nylon tape (ethicon) and transected with monopolar scissors.An intraoperative frozen biopsy of the pancreatic margin is performed to evaluate the cleanness of the resection margin.The reconstructive phase is performed on a single bowel loop passing behind the mesenteric vessels.A modified blumgart technique was adopted for fashioning the end-toside duct-to-mucosa pancreatico-jejunostomy, performing two interrupted horizontal mattress sutures between the pancreatic parenchyma and the sieromuscolar layer of the jejunum, while the duct-to-mucosa was approximated with interrupted 5-0 polydioxannone sutures (pds®; ethicon).A single-layer end-to-side hepaticojejunostomy is constructed with running 5-0 vicryl (rb1, ethicon) suture at approximately 10 cm from the pancreaticojejunostomy.Reported complications included wound infection (n=1) that required reoperation, biochemical leaks (n=7) and were treated keeping the drains in place and measuring their out put on a daily basis, grade b pancreatic fistula (n=6) they were managed with somatostatine injections,total parental nutrition and antibiotics.Grade c pancreatic fistula (n=1) required an emergency second-look surgery on post-operative day 10 for a delayed intra-abdominal bleeding was managed through a debridement and a washout of the supramesocolic space for sepsis control.Grade a delayed gastric emptying (n=1) treated with antiemetic drugs and prolonged maintenance of the nasogastric tube, biliary fistula (n=2) with biloma formation that required the insertion of a pig-tail drain, and treated by percutaneous drainage.Bilio-enteric anastomotic stricture required a surgical revision of the anastomosis under t-tube insertion.

• Brand Name: NYLON TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE.
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12602478
• MDR Text Key: 282809013
• Report Number: 2210968-2021-09444
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention