MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number ENDOLOOPUNK

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

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

(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 regarding the additional events.Citation: int urol nephrol (2007) 39:989¿993; doi 10.1007/s11255-007-9186-x; published online: 1 march 2007.(b)(4).

Event Description

It was reported in a journal article with title: flank hernia and bulging after open nephrectomy: mesh repair by flank or median approach? report of a novel technique.This study reports a flank hernia surgical repair either with a flank incision or a median laparotomy with the implantation of a prosthetic mesh in a sublay technique and compare and evaluate prospective follow-up study in terms of their long-term results.From 1997 to 2006, 15 flank hernia repairs with a prosthetic mesh implantation were performed.From 1997 to 2001, seven patients (mean age 56±17 years, male n=4, female n=3) with flank hernias were managed with a standardized mesh implantation through the initial flank incision (flank group).Since 2001, eight patients (mean age 53±11 years, male n=5, female n=3) have undergone a hernia repair through a median laparotomy with the use of a prosthetic mesh overlapping the midline in a sublay technique (median group).In the flank group, a polypropylene mesh [prolene, ethicon endo-surgery (europe) gmbh, norderstedt, germany] was implanted, which was fixated with an interrupted braided polyester suture [ethibond, ethicon endo-surgery (europe) gmbh, norderstedt, germany].In the median group, following closure of the posterior rectus sheath with a running absorbable polydioxanone loop suture [pds ii, ethicon endo-surgery (europe) gmbh, norderstedt, germany], a polypropylene mesh [prolene, ethicon endo-surgery (europe) gmbh, norderstedt, germany] and after 2003 a lightweight and partially absorbable mesh [vypro and ultrapro, ethicon endo-surgery (europe) gmbh, norderstedt, germany] was placed and fixed with sutures on the posterior rectus sheath.The anterior rectus sheath was then closed with an absorbable polydioxanone loop suture [pds ii, ethicon endo-surgery (europe) gmbh, norderstedt, germany].Complications in the flank group included seroma (n=6), wound infection (n=2), subileus (n=1), recurrence (n=2) and persistent flank bulge (n=7).Complications in the median group included seroma (n=5), wound infection (n=1).In conclusion, surgical repair of an incisional flank hernia with the use of a prosthetic mesh extending to the contralateral abdominal wall is a safe and effective method that enables a remodeling abdominal wall.Compared to our described novel technique the laparoscopic approach has advantages as far as the operative trauma is concerned.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8915921
• MDR Text Key: 155471047
• Report Number: 2210968-2019-85931
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENDOLOOPUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention