MAUDE Adverse Event Report: ETHICON INC. VCL RAP UD 18IN 5-0 S/A P-3 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VR493
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to receive a device for evaluation.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.Additional information was requested, and the following was obtained: was the surgery delayed due to the issue? no further information is available.What was used to complete the procedure? no further information is available.Was the surgery completed successfully? no further information is available.Device return follow up.We regularly contact about the device returning.No further information will be provided.
Event or Problem Description
It was reported that the patient underwent a rectal resection on (b)(6) 2020 and the suture was used.During the procedure, when opening the package, it was found that the needle tip had been broken.There were no patient consequences reported.

• Brand Name: VCL RAP UD 18IN 5-0 S/A P-3 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9986367
• Report Number: 2210968-2020-03349
• Device Sequence Number: 4355377
• Product Code: GAM
• UDI-Device Identifier: 10705031134676
• UDI-Public: 10705031134676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033746
• 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
• Report Date (Section B): 03/30/2020

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: VR493
• Device Catalogue Number: VR493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1