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

Model Number	VLOCN0326
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/08/2020
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, the patient undergo a tissue closure of the abdominal wall on a robotic ventral hernia procedure, and when the patient was about to wake up after the procedure, it was reported that the thread broke and in physically disengaged into separate pieces at the middle of the stitch.To resolve the issue the surgeon had to put back the patient into sleep, and they had to open the patient to re-do the closing of the defect from the top in order to complete the case.The surgical time was extended more than 30 minutes, and patient had longer time under anesthesia.

• 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: 10116245
• Report Number: 1219930-2020-02250
• Device Sequence Number: 11300769
• Product Code: GAT
• UDI-Device Identifier: 20884521127880
• UDI-Public: 20884521127880
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2020

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: 12/31/2020
• Device Model Number: VLOCN0326
• Device Catalogue Number: VLOCN0326
• Device Lot Number: A7M0291VX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/03/2020
• 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
• Patient Age: 62 YR