MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCL1413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
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, during a video assisted thoracoscopic surgery, when the surgeon threaded through the loop, the loop broke.The procedure was completed with another device.No patient injury was reported.
Additional Manufacturer Narrative
Change reportability, reportable to not reportable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC 180
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7646112
• Report Number: 1219930-2018-03475
• Device Sequence Number: 1512512
• Product Code: GAM
• UDI-Device Identifier: 20884521131450
• UDI-Public: 20884521131450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: 09/30/2020
• Device Model Number: VLOCL1413
• Device Catalogue Number: VLOCL1413
• Device Lot Number: A7J0321VFX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1