MAUDE Adverse Event Report: ETHICON, LLC COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	J840D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Putting in the final stitch to close the vaginal cuff the pop off needle being returned was missing the end piece (where suture is swedged on).(0 vicryl ct-1 j840d lot # pmb943 exp 2/29/2024) doctor came to consult after surgeon examined the vaginal tissue and could not find missing piece.The needle pulled through easily and was considered not likely to be in the tissue, x-ray was called.Then it was noticed one of the other needles had a needle tip missing.Searching the floor both pieces were found.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; route 22 west, p.o. box 151; somerville NJ 08876
• MDR Report Key: 8925991
• Report Number: 8925991
• Device Sequence Number: 2206957
• Product Code: GAM
• UDI-Device Identifier: 10705031043237
• UDI-Public: (01)10705031043237
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2019
• Report Date (Section F): 08/06/2019

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: Health Professional
• Device Model Number: J840D
• Device Catalogue Number: J840D
• Device Lot Number: PCM943
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 81
• Date Report Sent to FDA: 08/06/2019