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

Model Number	VLOCL0034
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, pre-operatively, the device¿s needle broke.The suture was not used because of the problem of decortication when leaving the packaging.New device was used to complete the case.Patient outcome was unknown.

• Brand Name: V-LOC 180
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORT HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 7053441
• Report Number: 1219930-2017-09014
• Device Sequence Number: 19099781
• Product Code: GAM
• UDI-Device Identifier: 20884521130460
• UDI-Public: 20884521130460
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 07/31/2019
• Device Model Number: VLOCL0034
• Device Catalogue Number: VLOCL0034
• Device Lot Number: A6G0780VX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1