MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 4-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP315H
Medical Device Problem Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
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.Was the (b)(4) - lot aj6856 needle removed from the patient during the same procedure? what is the condition of the patient?.
Event or Problem Description
It was reported that a patient underwent a lap cholecystectomy procedure on (b)(6) 2019 and suture was used.The needle fell while using it in the cavity.The thread was frayed.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device aj6856 number, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: was the code vcp315 - lot aj6856 needle removed from the patient during the same procedure? yes, the surgeon found the needle and removed it safely.What is the condition of the patient? the patient had no injuries, nor complications at all.The patient recover as expected.

• Brand Name: VCL+ VIO 27IN 4-0 S/A SH
• 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: 8833230
• Report Number: 2210968-2019-84713
• Device Sequence Number: 11409688
• Product Code: GAM
• UDI-Device Identifier: 10705031052215
• UDI-Public: 10705031052215
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 06/30/2019

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: 09/30/2022
• Device Catalogue Number: VCP315H
• Device Lot Number: AJ6856
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 08/07/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/07/2019; 08/29/2019
• Patient Sequence Number: 1