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

Model Number	VCP467H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by vet that the animal underwent an animal sterilization surgery on (b)(6) 2020 and the suture was used to ligate the ovary.It was reported that during procedure, the suture broke a bit from the needle end, but not in the knot.Another like suture was used to complete the procedure.

• Brand Name: VCL+ VIO 27IN 0 S/A CP-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9830446
• Report Number: 2210968-2020-02032
• Device Sequence Number: 11495337
• Product Code: GAM
• UDI-Device Identifier: 10705031053496
• UDI-Public: 10705031053496
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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 Expiration Date: 07/31/2022
• Device Model Number: VCP467H
• Device Catalogue Number: VCP467H
• Device Lot Number: PJBCLDT0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/13/2020
• Patient Sequence Number: 1