MAUDE Adverse Event Report: COVIDIEN SURGICAL V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	VLOCA008L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a procedure, the needle broke off in patient when attempting to close the vaginal cuff.To resolve the issue, the surgeon switched to straight stick suture and had to take a significant amount of time to look for the needle to be retrieved.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted one half of the needle was returned.The needle was returned broken at the swage.Instrument blade marks were observed outside the loading slot and on the cone.A segment of suture was returned with the needle.Functional testing was precluded as the needle was returned broken.It was reported that the needle broke off in patient when attempting to close the vaginal cuff.The reported issue could not be 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.The evaluation detected an unreported condition of 'premature toggle' that was not related to the reported condition.The product analysis noted evidence that the device was not used as intended.This issue can occur when pressure is applied on the toggle lever of the suturing device prior to closing the handles and prematurely attempting to toggle.Another unreported condition was detected of 'broken needle' that was not related to the reported condition.Internal process improvements have been initiated to mitigate this issue.The instructions included with this device provide the following guidance: ensure that the toggle levers are fully retracted prior to opening the jaws of the device.The reloading button should never be pressed when the instrument is in the body cavity, as this will release the needle.Inspect the application site to ensure hemostasis.Place additional sutures or use electrocautery if necessary to complete hemostasis.Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques.A thorough understanding of the operating principles, risks versus benefits, and the hazards involved in utilizing an endoscopic approach is necessary to avoid possible injury to the user and/or patient.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
According to the reporter during a procedure, the needle broke off in patient when attempting to close the vaginal cuff.
Additional Manufacturer Narrative
D10 concomitant products: 173016, 173016 endo stitch instrument (lot#:j4k4547ey) 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 180
• 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: 22455105
• Report Number: 1219930-2025-02877
• Device Sequence Number: 8218526
• Product Code: GAM
• UDI-Device Identifier: 10884521068278
• UDI-Public: (01)10884521068278(17)270228(10)N4C1860Y
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 09/03/2025

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 Model Number: VLOCA008L
• Device Catalogue Number: VLOCA008L
• Device Lot Number: N4C1860Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown