MAUDE Adverse Event Report: COVIDIEN MULTIFIRE ENDO HERNIA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	174027
Medical Device Problem Codes	Component or Accessory Incompatibility (2897); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, intra-operatively, the stapler fired without issue with the pre-loaded staples, but when the second reload was inserted, the stapler failed to correctly seat the staples.The staples fell out prior to firing.A new reload was used, but the same issue occurred with one side closing correctly and the other failing.The reloads were tested on another stapler which was opened and the reloads functioned correctly.The reloads were then checked on the original stapler and still failed to operate as it should.The issue resulted in less than 5 minutes of prolonged surgical time.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3 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
D10 concomitant products: unknown hernia, unknown hernia stapler, (lot # unknown); unknown hernia, unknown hernia stapler, (lot # unknown).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
According to the reporter, intra-operatively, the stapler fired without issue with the pre-loaded staples, but when the second reload was inserted, the stapler failed to correctly seat the staples.The staples fell out prior to firing.A new reload was used, but the same issue occurred with one side closing correctly and the other failing.The reloads were tested on another stapler which was opened and the reloads functioned correctly.The reloads were then checked on the original stapler and still failed to operate as it should.The issue resulted in prolonged surgical time.There was no patient injury.

• Brand Name: MULTIFIRE ENDO HERNIA
• 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: 24385852
• Report Number: 2647580-2026-00470
• Device Sequence Number: 10240449
• Product Code: GCJ
• UDI-Device Identifier: 10884521070608
• UDI-Public: (01)10884521070608(17)290228(10)P4C0908
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K912097
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 174027
• Device Catalogue Number: 174027
• Device Lot Number: P4C0908
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/02/2026
• Date Device Manufactured: 03/13/2024
• 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 H11.
• Patient Sex: Unknown