MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A UR-5; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP376H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mhz765 batch number, and no non-conformances were identified.Attempts have been made to retrieve the device.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.Were there any adverse patient consequences? this medwatch report is in response to receipt of maude event report mw# 5094254.
Event or Problem Description
It was reported that a laparoscopic procedure on (b)(6) 2020 and suture was used.During fascia closing, the suture needle broke.The broken needle was retrieved from the patient.X-ray showed no retained metallic foreign body.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 0 S/A UR-5
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10086740
• Report Number: 2210968-2020-04101
• Device Sequence Number: 2392736
• Product Code: GAM
• UDI-Device Identifier: 10705031052895
• UDI-Public: 10705031052895
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: VCP376H
• Device Catalogue Number: VCP376H
• Device Lot Number: MHZ765
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1