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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Seroma (2069); Hernia (2240); Not Applicable (3189)

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.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (endoloop pds suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product (endoloop pds suture) used in this procedure? citation: surg endosc (2016) 30: 4544¿4552; doi 10.1007/s00464-016-4791-3.(b)(4).

Event Description

It was reported via journal article: title: "review of 1000 fibrin glue mesh fixation during endoscopic totally extraperitoneal (tep) inguinal hernia repair." author(s): christophe r.Berney, joseph descallar.Citation: surg endosc (2016) 30: 4544¿4552; doi 10.1007/s00464-016-4791-3.This ongoing prospective cohort study aimed to validate the initial findings with a significantly larger group of patients and to mainly assess postoperative satisfaction levels and quality of life (qol) using a comprehensive scoring system specifically designed for hernia repairs.Over a 10-year period, between feb2005 and "feb2015m" 703 patients undergoing elective endoscopic totally extraperitoneal (tep) inguinal hernia repair were included in the analysis for unilateral inguinal hernia (n=406) and bilateral inguinal hernia (n=297).In the presence of a moderate (m2) or large (m3) sized medial (direct) hernia, the weakened transversalis fascia (tf) was plicated with a prettied of 2/0 pds endoloop ligature in order to reduce the incidence of postoperative seroma formation.At first visit postoperatively, three patients with a m3 defect were found to have a very small palpable but not symptomatic groin seroma that was not visible on inspection alone.All seromas were no longer detectable at 6 weeks post-surgery.One male patient developed early postoperative preperitoneal hernia formation as a result of a slipped prettied endoloop of the pds that was initially used to close the peritoneal sac opening after tep repair of an inguinoscrotal hernia.This patient was treated laparoscopically and made a full recovery with no further complaint.Since the incident of slipped prettied endoloop, it has been common practice to apply a second pretied suture at the base of the inverted tf when the defect is too large (m3).

Manufacturer Narrative

(b)(4).Date sent to the fda: 01/24/2019.Additional information was requested and the following was obtained: were the cases discussed in this article previously reported to ethicon? no.Does the surgeon believe that ethicon product (endoloop pds suture) involved caused and/or contributed to the post-operative complications described in the article? yes, the endoloop pds suture indirectly contributed to the early recurrence as it was not strong enough to maintain complete closure of the weakened transversalis fascia.Having said that, it only occurred on one occasion out of several hundred similar procedures done by me.This is a very good device that i employ on a regular basis and i also advise surgical trainees, fellows or other visiting consultant surgeons to use my technique with this endoloop of pds, in combination with fibrin glue for mesh fixation.I have the largest single surgeon series in the world (fibrin glue mesh fixation & endoloop pds) and can assure you that this technique is extremely reliable and safe as we don't require tackers in the groin anymore, with significant reduction of acute or chronic pain.Does the surgeon believe there was any deficiency with the ethicon product (endoloop pds suture) used in this procedure? not at all.

• 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
• MDR Report Key: 8196796
• MDR Text Key: 131417795
• Report Number: 2210968-2018-78029
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention