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

Model Number	VLOCN0605
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	08/31/2018
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, when the suture was being placed through the port during a procedure, the needle detached and fell off.They used new suture to complete the case.
Event or Problem Description
According to the reporter, when the suture was being placed through the port during a laparoscopic colorectal procedure, the needle detached.Needle holder was held on the suture body, however, when they maneuvering through the port the needle dislodged and fell straight through the port into the patient, yet they managed to retrieve.They used new suture to complete the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the returned product noted two sutures and two needles.The needle was returned disengaged from the suture.Upon microscopic inspection of the needle, normal crimp and swage marks were noted.The second suture was returned with the suture broken.It was observed, under magnification, that the second suture appeared to have split under tension.Unfortunately, as no sealed samples were returned, a needle attachment test could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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 NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7905699
• Report Number: 1219930-2018-05199
• Device Sequence Number: 1653800
• Product Code: GAT
• UDI-Device Identifier: 10884521171077
• UDI-Public: 10884521171077
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K103052
• 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,Followup,Followup
• Report Date (Section B): 01/04/2019

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: 12/31/2020
• Device Model Number: VLOCN0605
• Device Catalogue Number: VLOCN0605
• Device Lot Number: A7M0561VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 12/10/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/02/2018; 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1