MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCM1204
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
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 a transabdominal pre-peritoneal, the device loop broke, and when they used second device, the needle detached.The case was completed with another device.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of two devices opened by the account with the appropriate packaging in an undamaged condition.The visual inspection of the returned products noted two sutures and two needles.Both the needles were observed to be attached to the suture.One of the sutures loop was observed to be broken and the other loop was observed to be intact.The retainer was inspected with no abnormalities.Because the needles are attached to a suture, the reported condition was not confirmed.As no sealed products were returned, functional testing was precluded.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer's quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC 90
• 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: 7296366
• Report Number: 1219930-2018-01046
• Device Sequence Number: 13785103
• Product Code: GAM
• UDI-Device Identifier: 00884521132767
• UDI-Public: 00884521132767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 06/30/2020
• Device Model Number: VLOCM1204
• Device Catalogue Number: VLOCM1204
• Device Lot Number: A7F0793VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1