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

Model Number	VLOCN006L
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	11/18/2019
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 sleeve gastrectomy hiatus repair, while repositioning stomach after the procedure, surgeon attempted to load the device but was not successful.It was also reported that the suture fell off into patient's abdomen and was retrieved by graspers.Surgeon removed the suture in order to resolve the issue in order to complete the case but surgeon experienced difficulty in unloading the device.No patient injury.
Additional Manufacturer Narrative
Additional information: g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that there were no abno rmalities that would have caused or contributed to the reported condition.The returned needle was loaded into a returned device and applied to test media for functional testing.The returned needle was found to function properly and remained engaged in the test i nstrument throughout testing.No difficulty was experienced in loading, unloading or toggling the returned needle.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.\f information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9519698
• Report Number: 1219930-2019-07154
• Device Sequence Number: 458355
• Product Code: GAT
• UDI-Device Identifier: 10884521068827
• UDI-Public: 10884521068827
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/18/2020

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: 04/18/2019
• Device Model Number: VLOCN006L
• Device Catalogue Number: VLOCN006L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1