MAUDE Adverse Event Report: COVIDIEN LP LLC V-LOC; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	VLOCN008L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.The visual inspection of the sample noted one suture and one needle.Microscopic inspection of the loop noted material transfer which is an indication that the loop was welded.This serves as evidence that the loop was broken under tension; however, since the sample was received with the loop open, the force required to break the loop cannot be reliably determined.Additionally, the foil was inspected with light assisted microscopy with no abnormalities.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Unfortunately, since no sealed samples were received, a laced through loop test and needle attachment test could not be performed.The most likely root cause for the observed condition was determined to be a result of incorrect handling during application of the suture or excessive tension on the suture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a roux-en-y gastric bypass.The loop at the end of the suture strand came open/undone during the last step of the procedure.To correct the issue, the suture strand was removed and replaced.No known consequence or impact to patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP LLC; 60 middletown ave; north haven CT 06473
• MDR Report Key: 6531804
• Report Number: 1219930-2017-05408
• Device Sequence Number: 14518
• Product Code: GAT
• UDI-Device Identifier: 20884521073606
• UDI-Public: 20884521073606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2016

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: 08/31/2019
• Device Model Number: VLOCN008L
• Device Catalogue Number: VLOCN008L
• Device Lot Number: N6H0695X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Initial Date Received by Manufacturer: 12/29/2016
• Supplement Date Received by Manufacturer: 12/29/2016
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1