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

Model Number	VLOCN006L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter, during a lap nissen, while suturing the gastric wrap together, the thread of the device broke.Another device was used to complete the procedure.No patient injury noted.
Additional Manufacturer Narrative
Product analysis: product analysis was created by the (b)(4) pmv lab as part of the receipt process, so that decontamination could be documented in (b)(6).This product analysis activity is being marked as ¿complete¿ and the investigating site will create another product analysis activity upon receipt.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 one device.The visual inspection of the sample noted one suture and one needle.The loop was received open, and it was observed, under magnification, that it appeared to have broken under tension.Under microscopic inspection, evidence of material transfer was observed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all 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
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 6813823
• Report Number: 1219930-2017-06604
• Device Sequence Number: 1735470
• Product Code: GAT
• UDI-Device Identifier: 20884521068824
• UDI-Public: 20884521068824
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2018

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: 03/31/2019
• Device Model Number: VLOCN006L
• Device Catalogue Number: VLOCN006L
• Device Lot Number: N6C0845X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 12/06/2017; 12/21/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 12/19/2017; 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1