MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE WITH COATED VICRYL; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EJ10G03

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

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 was met prior to the release of this lot.

Event Description

It was reported that a patient underwent a laparoscopic appendectomy procedure on (b)(6) 2017 and suture was used.During the procedure, prior to use on the patient, when the package was opened, micro punctures in the foil were noted.When held up to light, the staff could see light through the foil.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.

• Brand Name: ENDOLOOP LIGATURE WITH COATED VICRYL
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6915214
• MDR Text Key: 88225125
• Report Number: 2210968-2017-70418
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: EJ10G03
• Device Lot Number: GCX239
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/12/2017
• Date Device Manufactured: 03/01/2013
• 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