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

Model Number	VLOCN0615
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during an open gastrectomy procedure, the loop of the suture was found to be broken.The issue was resolved by using another suture.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The two devices were available for evaluation.Also, a dif ferent device was returned than was originally reported.Ten sealed samples that were representative of the complaint lot.Visual inspection noted two needles and two sutures.The needles were returned attached to their sutures.One suture was returned with the loop broken.The other was returned intact.A tactile and microscopic inspection of the suture was performed with no abnormalities.On the representative samples a tactile and microscopic inspection of the sutures was performed with no abnormalities.The breathable pouches were inspected and identified no damage or visual abnormalities.Functional testing found on the representative samples noted the breathable pouches were opened without any tears of the tyvek packaging.The sutures were removed from the retainers without any difficulty.Each suture was fed through the loop at the end of the suture in and pulled until a small loop was formed.The suture ends were loaded onto an instron machine by looping the newly formed loop around a mounting pin attached to manual grips and clamping one end with cord yarn grip.No suture breaking or fraying was noted while handling/loading the suture into the instron machine.The instron then pulled the suture at a rate of 300 mm/min until the suture broke or the loop failed.The breaking point load force was measured and were found to meet minimum mean and minimum individual specifications.Based on the results of the laced-through loop test, the representative samples tested satisfactory.It was reported that the loop of the suture was found to be broken.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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
• 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: 23849318
• Report Number: 1219930-2025-05918
• Device Sequence Number: 9958229
• Product Code: GAT
• UDI-Device Identifier: 10884521135291
• UDI-Public: (01)10884521135291(17)260228(10)A3C0722VY(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 02/28/2026
• Device Model Number: VLOCN0615
• Device Catalogue Number: VLOCN0615
• Device Lot Number: A3C0722VY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2023
• 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
• Patient Sex: Unknown