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

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Hematoma (1884); Unspecified Infection (1930); Blood Loss (2597); No Code Available (3191)

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.No specific patient information regarding events has 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.Does the surgeon believe that 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 the ethicon products used in this procedure? citation: langenbecks arch surg.2016; 401: 661 666.Doi: 10.1007/(b)(4) - [(b)(4) - soll 2016.Pdf].

Event Description

It was reported via journal article: ¿title: appendiceal stump closure using polymeric clips reduces intra-abdominal abscesses¿ authors: christopher soll, paloma wyss, hans gelpke, dimitri aristotle raptis, stefan breitenstein citation: langenbecks arch surg.2016; 401: 661 666.Doi: 10.1007/(b)(4).The aim of this study was to compare the hem-o-lock ligation system with conventional devices.A total of 813 patients underwent laparoscopic appendectomy and were included in the study.Of which, 435 patients used hem-o-lok clips and 378 patients used endoloop ligatures.During the procedure, hem-o-lok clips or pds endoloop 2-0 ligatures were used in laparoscopic appendectomy without inflammation of the base of the appendix while endo-staplers were applied in complicated cases.Patients treated with hem-o-lok clips were compared with those who received pds endoloop 2-0 ligatures.The primary outcome measure was the rate of post-operative intra-abdominal abscesses according to the definition of surgical site infections.In the endoloop group, reported complications included post-operative intra-abdominal abscess (n-15), superficial or deep incisional infection (n-3), bleeding (n-2), hematoma (n-6), and ileus (n-2).It was concluded that hem-o-lok clips provide a safer and cheaper closure of the appendiceal stump.For these reasons, hem-o-lok clips are preferred as the technique of choice to close the appendiceal stump in uncomplicated appendicitis in our clinic.

• 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: 7447057
• MDR Text Key: 106059749
• Report Number: 2210968-2018-72206
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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: 03/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention