MAUDE Adverse Event Report: COVIDIEN AUTO SUTURE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	OMS-T10BTNL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: oms-t10btnl, omst10btnl 10 blunt tip trocar w/o latex (lot# p5j1071).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 the laparoscopic urological procedure, part of the trocar ring was detached during the surgery.The component did not fell into the patient cavity.The trocar was replaced to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Correction: d9 (correct return date) additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.A visual inspection of the returned photos noted that the two received images depict the end of the cannula minus the blunt tip part.The balloon was peeled back from its original position on the cannula.It was reported that during the laparoscopic urological procedure, part of the trocar ring was detached during the surgery.The component did not fell into the patient's cavity.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when excessive force is applied during clinical application.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: damage to the balloon by instruments used during insertion and in the course of a procedure may cause device failure.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: AUTO SUTURE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24292731
• Report Number: 2647580-2026-00309
• Device Sequence Number: 10382243
• Product Code: GCJ
• UDI-Device Identifier: 10884521527386
• UDI-Public: (01)10884521527386(17)280831(10)P5J1071(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K924011
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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 Model Number: OMS-T10BTNL
• Device Catalogue Number: OMS-T10BTNL
• Device Lot Number: P5J1071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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