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

Model Number	OMS-T10BT
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
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 procedure, the balloon did not inflate.The device was exchanged for a new product to resolve the issue.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 device was received with the obturator inserted into the cannula.The trocar balloon appeared intact.The lock collar was broken.The inflation syringe was received.Functional testing found that the obturator was removed and the main valve seal was disengaged and on the shaft of the obturator.The converter doors were intact and moved properly and were fixed securely in place.The balloon was inflated using the returned syringe, no leaks detected however an odd shape was noted.It was reported that the balloon would not inflate.The reported issue was not confirmed.The product analysis noted evidence that the device was not used as intended.The evaluation detected an unreported condition: disengaged seal.This issue can occur when excessive force is applied during clinical application.Another unreported condition was identified: balloon irregular shape.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.Another unreported condition was identified: broken lock collar.This issue can 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.Once the extraperitoneal space is adequately dissected, deflate the dissection balloon by removing the endoscope or by removing the inflation bulb from the dissector.Damage to the balloon by instruments used during insertion and in the course of a procedure may cause device failure.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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: 24729761
• Report Number: 2647580-2026-00875
• Device Sequence Number: 9269813
• Product Code: GCJ
• UDI-Device Identifier: 10884521080874
• UDI-Public: (01)10884521080874(17)261231(10)P4A1156
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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-T10BT
• Device Catalogue Number: OMS-T10BT
• Device Lot Number: P4A1156
• 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: 03/29/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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
• Patient Sex: Unknown