MAUDE Adverse Event Report: COVIDIEN GIA; STAPLER, SURGICAL

Model Number	GIA8038S
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: gia8038l gia 80-3.8sgl use loadingunit (lot#: p4e0822s) 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 an open partial hepatectomy, the handle and reload partially fired and could not continue operation after the black handle was pushed halfway.The surgeon attempted to resolve the issue by replacing the device with a new reload, but the device still could not continue.The surgeon then replaced it with a new handle and completed the procedure.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 welded pin of the hinge component on the anchored lever bracket was bent away from the anchored lever bracket.It was reported that the device experienced partial firing.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when the instrument is closed without engaging the anchor bracket posts, a large gap is observed between the cartridge and anvil.Applying external pressure at the fork areas of the instrument to force it together to close causes the separation of the anchor bracket at the posts.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: GIA
• Common Device Name: STAPLER, SURGICAL
• 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: 23952497
• Report Number: 2647580-2026-00012
• Device Sequence Number: 20800517
• Product Code: GAG
• UDI-Device Identifier: 10884523007268
• UDI-Public: (01)10884523007268(17)290831(10)P4J0958S(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/09/2026

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: GIA8038S
• Device Catalogue Number: GIA8038S
• Device Lot Number: P4J0958S
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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 NOTE ON H11
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 79 KG