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

Model Number	OMS-T12BTNL
Medical Device Problem Codes	Decrease in Pressure (1490); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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 a laparoscopic inguinal hernia procedure, the valve seal of the trocar became unglued and disengaged when the surgeon attempted to introduce mesh into the abdominal cavity through the trocar port.The valve seal detached and nearly fell into the patient cavity, but the surgeon was able to catch it before this occurred.There was a rapid loss of abdominal pressure due to the device issue.The device was replaced with a competitive trocar to complete the case.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 device was available for evaluation.Visual inspection noted that the main valve seal was partially disengaged.The converter door and disengaged main valve seal were jammed and could not be removed.The balloon, lock collar, and obturator were intact.The inflation syringe was not received.During functional testing, the balloon was inflated using a test inflation syringe, it had an odd shape and no leaks were detected.The lock collar move up and down the cannula and snapped securely in place.It was reported that the seal disengaged.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.Internal process improvements have been initiated to mitigate this issue.It was also reported that there was rapid loos of pneumoperitoneum.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 'the balloon irregular shape' 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 positioning the device during its inflation deployment or deflation process, or its tissue planes process, during clinical application.The instructions included with this device provide the following guidance: once the extraperitoneal space is adequately dissected, deflate the dissection balloon by removing the endoscope or by removing the inflation bulb from the dissector.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: 23473827
• Report Number: 2647580-2025-03292
• Device Sequence Number: 13393562
• Product Code: GCJ
• UDI-Device Identifier: 10884521552449
• UDI-Public: (01)10884521552449(17)280731(10)P5H0842(20)02
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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-T12BTNL
• Device Catalogue Number: OMS-T12BTNL
• Device Lot Number: P5H0842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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
• Patient Age: 65 YR
• Patient Sex: Male