MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Catalog Number ER320

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); No Code Available (3191)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unknown.Maude report # mw5081384.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.Please explain what is meant by, ¿patient returned to hospital 20 with abdominal pain.¿ was this (b)(6), 20 hours after discharge, 20 days post discharge)? were there any clip formation issues noted during the care of the patient? during the reoperation, were there clips identified? if yes, what was there location and shape? was there any twisting or torqueing of the device when applying the clips? are there photos or video of the surgical procedure or clips available? if yes, could you please send to (b)(6).

Event Description

It was reported that during a laparoscopic cholecystectomy procedure: ¿patient went to operating room for laparoscopic cholecystectomy on (b)(6) 2018.Operation appeared normal and patient went home.Patient returned to the hospital on "20" abdominal pain.Patient back to operating room for a bile leak.Patient had a diagnostic laparoscopy with irrigation and wash out done.Drain placed.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8209174
• MDR Text Key: 131843089
• Report Number: 3005075853-2019-15434
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: ER320
• Device Lot Number: R40F35
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1