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

Model Number	VLOCA208L
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparoscopic hysterectomy, while suturing the vaginal cuff, the needle snapped in half, with one half remaining lodged in the handle and the other half breaking off inside the tissue of the vaginal cuff.The handle was described as difficult to unload.This resulted in an increase in bleeding not more than 500cc, including excess tissue removal and enlargement of the vaginal cuff.The incision was extended by more than one inch, and more tissue had to be resected to locate and recover the needle fragment lodged in the tissue.
Additional Manufacturer Narrative
D10 concomitant product: 173016 endo stitch instrument (lot#: j5k4472ey) 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: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photographs were available for evaluation.Evaluation of the images noted one breather pouch (lot: n4a2413y), and one endostitch display box (ref: 173016, lot: j5k4472ey).Additionally, two images showed a member of the operating room team holding fragments of a broken endostitch needle.It was reported that the needle snapped in half, a device component was disengaged, and the needle was difficult to unload.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when pressure is applied on the toggle lever of the suturing device prior to closing the handles, and prematurely attempting to toggle/ pass the needle through tissue.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: to guide the needle through the tissue, close the jaws by completely squeezing the handles and reversing the position of the toggle levers until they stop.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: 24334552
• Report Number: 1219930-2026-00908
• Device Sequence Number: 15888908
• Product Code: GAM
• UDI-Device Identifier: 10884521068285
• UDI-Public: (01)10884521068285(17)261231(10)N4A2413Y
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: VLOCA208L
• Device Catalogue Number: VLOCA208L
• Device Lot Number: N4A2413Y
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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 NOTE ON H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female