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

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

Patient Problem Pain (1994)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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? 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? is the patient death directly related to the endoloop? if yes, please provide specifics.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.Component code: (b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: annals of medicine and surgery (2021); 65(102364):1-4.Doi: https://doi.Org/10.1016/j.Amsu.2021.102364.

Event Description

Title: endoloops in laparoscopic appendicectomy: a retrospective, cost effectiveness analysis.The aim of this retrospective study was to investigate whether a significant difference in complication rate exists where different numbers of endoloop ligatures have been applied to the appendiceal base during laparoscopic appendicectomy, and to analyse for potential cost saving.Between january 1st to december 31st, 2020, a total 195 patients who underwent appendicectomy were included in the study.The particular device used is the ethicon endoloop® ligature made with pds® ii.Among the patients, one endoloop was used in 133 patients while two endoloops were used in 62.Reported complications include postoperative pain (n=6), postoperative collection (n=6) requiring radiologically-guided drainage in 2 patients or laparotomy and washout in 1.In conclusion, our study set out to assess whether the complication rate differs in cases where one or two endoloops have been applied.Retrospective statistical analysis found no significant difference between groups.Therefore, we recommend use of one endoloop to secure the base in laparoscopic appendicectomy.

Manufacturer Narrative

Product complaint # (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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13010640
• MDR Text Key: 286467821
• Report Number: 2210968-2021-12610
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 12/27/2021
• Supplement Dates FDA Received: 01/12/2022
• 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