MAUDE Adverse Event Report: COVIDIEN SURGICAL V-LOC; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	VLOCN206L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unintended Radiation Exposure (4565); Insufficient Information (4580)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparoscopic procedure, a total of 38 devices had their needles breaking off.
Additional Manufacturer Narrative
D10 concomitant products: vlocn206l, vlocn206l v-loc estch 2-0 nonabs 15cm lp, (lot number: n5c1790y) vlocn206l, vlocn206l v-loc estch 2-0 nonabs 15cm lp, (lot number: n4f1618y) vlocn206l, vlocn206l v-loc estch 2-0 nonabs 15cm lp, (lot number: n4f1618y) vlocn206l, vlocn206l v-loc estch 2-0 nonabs 15cm lp, (lot number: n5c1790y) vlocn206l, vlocn206l v-loc estch 2-0 nonabs 15cm lp, (lot number: n5c1790y) vlocn206l, vlocn206l v-loc estch 2-0 nonabs 15cm lp, (lot number: n5c1790y) vlocn206l, vlocn206l v-loc estch 2-0 nonabs 15cm lp, (lot number: n5c1790y) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: b1, b2, b3, b6, g3, h1, h6 new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a laparoscopic procedure, two devices had their needles breaking off.An x-ray was performed to confirm the location of the broken pieces.
Additional Manufacturer Narrative
Correction: b5 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a laparoscopic procedure, two devices had their needles breaking off.An x-ray was performed to confirm the location of the broken pieces.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.A different device was returned than was originally reported.A device sealed with the appropriate packaging that were representative of the complaint lot.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the needle was breaking off.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: V-LOC
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24373396
• Report Number: 1219930-2026-01057
• Device Sequence Number: 14687945
• Product Code: GAT
• UDI-Device Identifier: 10884521068834
• UDI-Public: (01)10884521068834(17)270531(10)N4F1618Y
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K111442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/28/2026

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 Model Number: VLOCN206L
• Device Catalogue Number: VLOCN206L
• Device Lot Number: N4F1618Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 03/03/2026; 04/15/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/03/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown