MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; CANNULA, SURGICAL, GENERAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Unspecified Infection (1930); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 04/13/2018.(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.If further details are received at the later date a supplemental medwatch will be sent.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that any deficiency of the ethicon product endoloop or pds suture caused and/or contributed to the adverse events described in the article? citation: can j surg, vol.55, no.1, february 2012.[(b)(4)].

Event Description

It was reported in journal article title: endoloop versus endostapler closure of the appendiceal stump in pediatric laparoscopic appendectomy authors : arash safavi, md, monica langer, md, erik d.Skarsgard, md doi: 10.1503/cjs.023810 citation: can j surg, vol.55, no.1, february 2012.The aim of this study was to compare infectious outcomes between 2 laparoscopic techniques of appendiceal stump closure: endoloop (el) and endostapler (es).A total of 242 patients underwent la during the study period and had complete data sets abstracted retrospectively from their medical records.The patient were divided into 2 groups: non-perforated appendicitis (npa) n=185, perforated appendicitis (pa) n=57.One surgeon used the es (ethicon endosurgery) in all cases (pa and nonperforated appendicitis [npa]) whereas 2 surgeons routinely used el unless the condition of the appendiceal base favoured use of an es to ensure sealing of healthy tissue.Endoloop stump closure consisted of 2 proximal and 1 distal 2¿0 polydioxanone (pds; ethicon) els, with division of the appendiceal base between the middle and distal el.Surgical site infections (npa (n=2); pa (n=2)) and intra-abdominal abscess formation (npa (n=5); pa (n=6) with the use of el were reported.Intra-abdominal abscess formation (n=5) with the use of endostapler was also reported.In conclusion, this study suggests that preferential use of el for appendiceal stump closure in la is associated with at least equivalent infectious outcomes, as well as cost savings, in comparison to routine use of es.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: CANNULA, SURGICAL, GENERAL
• 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: 7429388
• MDR Text Key: 105513340
• Report Number: 2210968-2018-72128
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• 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