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

Model Number	VLOCN1126
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively of a laparoscopic total extraperitoneal procedure ,on fascia closure, the thread of the device broke after the procedure.A reoperation was needed, the hospitalization was prolonged for one day.No patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of two images of the device.Visual inspection of the first image noted about seven pieces of broken sutures.None of the suture pieces had a needle attached.The second image noted the suture used in surgery which did not have a needle attached.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Event or Problem Description
According to the reporter, post-operatively of a laparoscopic total extraperitoneal procedure, on fascia closure, the thread of the device broke after the procedure.A reoperation was needed, the hospitalization was prolonged for one day.The anterior fascia did not stay sutured because the thread broke.The first closure was done laparoscopically, the second time was open.The patient is good.

• Brand Name: V-LOC
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7123232
• Report Number: 1219930-2017-10009
• Device Sequence Number: 2037390
• Product Code: GAT
• UDI-Device Identifier: 20884521127927
• UDI-Public: 20884521127927
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K103052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 10/31/2018
• Device Model Number: VLOCN1126
• Device Catalogue Number: VLOCN1126
• Device Lot Number: A5K1082VWX
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 02/23/2018
• 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: Hospitalization; Required Intervention