MAUDE Adverse Event Report: COVIDIEN SURGICAL V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	VLOCM0023
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during breast tumor removal and breast reconstruction, the connection between the suture needle and the suture suddenly detached, and the suture needle was instantly ejected due to its elasticity.The doctor initially judged this as needle breakage.After a preliminary search, the needle was not found at the wound site, so the wound was first sutured and the patient was sent to the waiting room.The surgical staff continued searching in the operating room for about half an hour, but to no avail.Radiology was then contacted, and the patient was brought into the operating room for an x-ray of the wound area.The suture needle was found not to have fallen outside the surgical field, but had instead dropped directly into the patient's surgical wound.The doctor immediately performed a procedure to retrieve the suture needle from the patient's wound.The issue was ultimately resolved successfully, and no other harm was caused to the patient.However, this incident objectively prolonged the operation time and posed a significant intraoperative safety risk to the patient.
Additional Manufacturer Narrative
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.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• 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: 23892349
• Report Number: 1219930-2025-06035
• Device Sequence Number: 5344045
• Product Code: GAM
• UDI-Device Identifier: 10884521131682
• UDI-Public: (01)10884521131682(17)270630(10)A4G1614VFY(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/25/2025

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: VLOCM0023
• Device Catalogue Number: VLOCM0023
• Device Lot Number: A4G1614VFY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/25/2025
• Date Device Manufactured: 07/02/2024
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Male