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

Model Number	VLOCA306L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
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 laparoscopic gastric bypass, when closing mesenteric window 2 sutures fell of from the point of attachment in the device.A third reload was used to complete the case, the same handle was used throughout the procedure.There is no patient harm.
Additional Manufacturer Narrative
Evaluation summary: the product sample or additional supporting materials from the account was not available for this incident.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Without the physical product, a definitive root cause could not be identified.Post market vigilance will continue to monitor this condition for future potential action.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: 8679986
• Report Number: 1219930-2019-03344
• Device Sequence Number: 16648434
• Product Code: GAM
• UDI-Device Identifier: 10884521068155
• UDI-Public: 10884521068155
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K111442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 08/31/2021
• Device Model Number: VLOCA306L
• Device Catalogue Number: VLOCA306L
• Device Lot Number: N8H0782X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1