MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	EJ10G
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon requested the endoloop during a lap chole.The packaging is the same foil material as another ethicon product staffs have faced issues with.The rn opened 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 rn to place into garbage.The tech donned a new pair of sterile gloves aseptically and repeated process with second endoloop packaging intact.The packaging was saved for clinical engineering, and images of the pin prick holes were acquired using a microscope light to illuminate where the holes were located in the foil.Per site reporter: a complaint file has been opened and the package will be returned for failure analysis.

• Brand Name: ENDOLOOP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 7352168
• Report Number: 7352168
• Device Sequence Number: 19070639
• Product Code: GAM
• UDI-Device Identifier: 10705031206465
• UDI-Public: (01)10705031206465
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2018
• Report Date (Section F): 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 05/31/2021
• Device Model Number: EJ10G
• Device Catalogue Number: EJ10G
• Device Lot Number: AF1555
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 72
• Date Report Sent to FDA: 03/15/2018