MAUDE Adverse Event Report: ETHICON INC. 0 ENDOLOOP LIG W/PDS II; CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY

Catalog Number EZ10G

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Investigation summary: it was reported performance damaged product.An empty opened foil, a opened folder, a cannula and a pds suture in several pieces were returned for analysis.During the visual inspection of several suture pieces have begun with the process of degradation.Also, the foil was examined for visual inspection and showed multiples wrinkles and holes in cavity on bottom foil package due to excessive manipulation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of performance damaged product, was caused by suture degradation due to pin holes in cavity.

Event Description

It was reported that a patient underwent a cholecystectomy on (b)(6) 2018, and suture was used.During the procedure, the doctor was using the device for a cystic duct.The nurse went to remove the device from the packaging in order to use it in the operation.However, the product appeared to be brittle and broken prior to use with patient.There were no adverse patient consequences reported.Upon evaluation of the device, visual inspection of several suture pieces have begun with the process of degradation.Also, the foil was examined for visual inspection and showed multiples wrinkles and holes in cavity on bottom foil package due to excessive manipulation.No additional information was provided.

• Brand Name: 0 ENDOLOOP LIG W/PDS II
• Type of Device: CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 8245213
• MDR Text Key: 133064837
• Report Number: 2210968-2019-78386
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K843187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: EZ10G
• Device Lot Number: AE2166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1