MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCM0123
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2017
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 procedure, the thread broke and did not have a loop when the device was opened.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7203792
• Report Number: 1219930-2018-00419
• Device Sequence Number: 11057028
• Product Code: GAM
• UDI-Device Identifier: 20884521132235
• UDI-Public: 20884521132235
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

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: 08/31/2019
• Device Model Number: VLOCM0123
• Device Catalogue Number: VLOCM0123
• Device Lot Number: A6H0547VFX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1