MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB FAST; ABSORBABLE SURGICAL SUTURE

Model Number	CV-917
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "before the closing of the wound during an open procedure, when the gynecologist wanted to take the needle out of the package, the suture needle broke.A new suture was used to complete the case, no patient injury.

• Brand Name: VELOSORB FAST
• Common Device Name: ABSORBABLE SURGICAL SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland, or
• MDR Report Key: 10076571
• Report Number: 3006981798-2020-00004
• Device Sequence Number: 3218345
• Product Code: GAM
• UDI-Device Identifier: 10884521151659
• UDI-Public: 10884521151659
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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: No Information
• Device Model Number: CV-917
• Device Catalogue Number: CV-917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1