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

Model Number	VLOCN0605
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Tissue Damage (2104); Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic bypass procedure, while closing the mesenteric breach, the device needle broke and fell into the patient cavity.To resolve the issue, the surgeon had to perform an x-ray to locate the needle and to be able to retrieve it.The procedure was also converted from laparoscopic to an open procedure due to the problem.The surgical time was also extended for more than 30 minutes, and there was an extended incision for more than 1 inch or 2.54 cm.The patient had a permanent tissue damage.

• 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: 10196886
• Report Number: 1219930-2020-02523
• Device Sequence Number: 14048198
• Product Code: GAT
• UDI-Device Identifier: 10884521171077
• UDI-Public: 10884521171077
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: VLOCN0605
• Device Catalogue Number: VLOCN0605
• Device Lot Number: A9D0682VY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention