MAUDE Adverse Event Report: ETHICON INC. 0 ENDOLOOP LIG W/VCL CT VL; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EJ10G

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

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 were met prior to the release of this lot.

Event Description

It was reported that a patient underwent a laparoscopic cholecystectomy procedure and suture was used.The rn opened the package to the tech, but instructed the tech not to place item onto the surgical field as it may have pin-prick type holes in the foil.As expected, 8+ small holes were found in the product, indicating a breach in sterility.The tech removed the item and his glove to the rn to place into garbage.The tech donned a new pair of sterile gloves aseptically and repeated process with the second device with intact packaging.There were no patient consequences reported.

Manufacturer Narrative

Investigation summary
=
> an empty opened foil of product was returned for analysis.During the visual inspection of the opened foil, multiples wrinkles and holes in cavity were found on the bottom foil; however, the holes were from outside to inside and appears to be by excessive handling.Per the condition of the sample received the assignable cause suggests an improper handling.

• Brand Name: 0 ENDOLOOP LIG W/VCL CT VL
• 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.; rodovia presidente dutra; km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7495994
• MDR Text Key: 107694584
• Report Number: 2210968-2018-72658
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: EJ10G
• Device Lot Number: AF1555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Date Device Manufactured: 06/14/2016
• 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 Age: 61 YR
• Patient Weight: 72