MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 3X18IN 1 S/A OS-8 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP718T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 that the patient underwent an unknown surgical procedure on unknown date and the suture was used.During the procedure, the suture was broken during interrupted suturing.Another like suture was used to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device lk6972 number, and no non-conformances were identified.Additional information was requested and the following was obtained: we asked the sales rep but the actual device has not yet returned.

• Brand Name: VCL+ VIO 3X18IN 1 S/A OS-8 CR
• 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: 8793318
• Report Number: 2210968-2019-84322
• Device Sequence Number: 19327388
• Product Code: GAM
• UDI-Device Identifier: 10705031055063
• UDI-Public: 10705031055063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 06/19/2019

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 Expiration Date: 08/31/2022
• Device Catalogue Number: VCP718T
• Device Lot Number: LK6972
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1