MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VELOSORB FAST; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	SV-2253
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, right before using, the needles detaches from the strands.Additional suture was used without an issue.

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8046420
• Report Number: 1219930-2018-05896
• Device Sequence Number: 1653888
• Product Code: GAM
• UDI-Device Identifier: 10884521150942
• UDI-Public: 10884521150942
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

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: 03/31/2020
• Device Model Number: SV-2253
• Device Catalogue Number: SV-2253
• Device Lot Number: 17042617X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1