MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP260H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you confirm that the needle pieces were removed from the patient during the same procedure?.
Event or Problem Description
It was reported that the patient underwent a laparoscopic cholecystectomy procedure on (b)(6) 2019 and suture was used.The needle broke while pushing through the fascia.There were no fragments generated.The procedure was completed successfully without reported delay.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: can you confirm that the needle pieces were removed from the patient during the same procedure? - yes the needle pieces were all recovered.

• Brand Name: VCL+ UD 27IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8737201
• Report Number: 2210968-2019-83332
• Device Sequence Number: 14112673
• Product Code: GAM
• UDI-Device Identifier: 10705031051805
• UDI-Public: 10705031051805
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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 Catalogue Number: VCP260H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1