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

Model Number	OMS-T10SB
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the access step of a laparoscopic procedure, the trocar access balloon did not inflate.Four more units were opened and each had the same issue until a replacement product was used to complete the case.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10 concomitant products: oms-t10sb, oms-t10sb trocar balloon o armatures10, (lot number: p6a1002) oms-t10sb, oms-t10sb trocar balloon o armatures10, (lot number: p6a1002) oms-t10sb, oms-t10sb trocar balloon o armatures10, (lot number: p6a1002) oms-t10sb, oms-t10sb trocar balloon o armatures10, (lot number: p6a1002) 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: 25558013
• Report Number: 2647580-2026-01800
• Device Sequence Number: 21335282
• Product Code: GCJ
• UDI-Device Identifier: 10884521081086
• UDI-Public: (01)10884521081086(17)281231(10)P6A1002(20)02
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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-T10SB
• Device Catalogue Number: OMS-T10SB
• Device Lot Number: P6A1002
• 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: 06/16/2026
• Initial Report FDA Received Date: 06/19/2026
• Date Device Manufactured: 01/20/2026
• 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