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

Model Number	VCP340H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).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.
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn surgery on an unknown date and suture was used.During the procedure, when the surgeon checked the tip of the needle-holder by a camera, there was only a suture, and no needle was observed.The abdominal cavity was searched, but the needle could not be found.Finally, it was found that the needle had been caught on the subcutis of the wound.The operation time was extended within 30 minutes.The lot number is unknown.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 12/10/2020.Additional information: d9, h3, h6, h3 analysis summary: it was received for analysis an empty labeled winding former, a detached needle and a suture piece of product code vcp340h.During the visual inspection of the detached needle, the swage and attachment area were noted to be as expected.The barrel hole was examined under 20x magnification and no suture remnant was noted.The suture piece was examined, and the insertion end was observed to be as expected and the force used to detach needle from the suture could not be determined.No conclusion could be reached as on what caused that the needle had been detached from the suture.This report is being submitted pursuant to the provisions of 21 cfr, parts 4 and 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: VCL+ VIO 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
• MDR Report Key: 10781637
• Report Number: 2210968-2020-08625
• Device Sequence Number: 19101178
• Product Code: GAM
• UDI-Device Identifier: 10705031052499
• UDI-Public: 10705031052499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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 Model Number: VCP340H
• Device Catalogue Number: VCP340H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/10/2020
• Patient Sequence Number: 1