MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP218H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.
Event or Problem Description
It was reported that a patient underwent an endoscopic cholecystectomy procedure on (b)(6) 2019 and suture was used.It was reported that the needle tip was missing.During the procedure, the suture was used to sew the dermis.However, it was found that 1-2mm of the needle tip was missing when almost finishing sewing.With the help of an x-ray, it took about 2 hours to look for the needle tip, but finally failed to find it.The patient is now discharged from the hospital.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: please refer to the event description, no further information can be provided for the questions requested.

• Brand Name: VCL+ UD 27IN 4-0 S/A SH-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: 9269792
• Report Number: 2210968-2019-89424
• Device Sequence Number: 2498527
• Product Code: GAM
• UDI-Device Identifier: 10705031051706
• UDI-Public: 10705031051706
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 10/08/2019

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: No Information
• Device Catalogue Number: VCP218H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 11/02/2019
• Supplement Report FDA Received Date: 12/02/2019
• Patient Sequence Number: 1