MAUDE Adverse Event Report: ETHICON, INC. VICRYL PLUS SUTURE NEEDLE; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	UR-5
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During laparoscopic procedure a fascia closing suture needle broke.The broken needle was retrieved from the patient.X-ray showed no retained metallic foreign body.Fda safety report id# (b)(4).

• Brand Name: VICRYL PLUS SUTURE NEEDLE
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 9995140
• Report Number: MW5094254
• Device Sequence Number: 19352435
• Product Code: GAM
• UDI-Device Identifier: 10705031052895
• UDI-Public: (01)10705031052895
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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 Expiration Date: 06/30/2023
• Device Model Number: UR-5
• Device Catalogue Number: VCP376
• Device Lot Number: MHZ765
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR