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

Model Number	VLOCN0644
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 laparoscopic procedure, the "seal" of the welded loop came loose and therefore could not be used anymore.There was no injury caused to the patient and no medical intervention was required.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the sample noted two sutures.Both products were received with the loop open.The sutures were observed to be detached from needles, but the needles weren¿t returned.It was observed, under magnification, that each loop appeared to have split under tension.Upon microscopic inspection, evidence of material transfer was found at the weld site of each loop.As no sealed products were returned, functional testing was precluded.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.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: 7278585
• Report Number: 1219930-2018-00864
• Device Sequence Number: 1368028
• Product Code: GAT
• UDI-Device Identifier: 20884521134925
• UDI-Public: 20884521134925
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: 08/31/2020
• Device Model Number: VLOCN0644
• Device Catalogue Number: VLOCN0644
• Device Lot Number: A7H0458VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1