MAUDE Adverse Event Report: COVIDIEN GIA; STAPLER, SURGICAL

Model Number	GIA8038S
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the bowel resection, the handle broke.The stapler would just not engage or fire.The surgeon was unable to properly reattach the handle piece, so another stapler from a different lot number was opened and used to resolve the issue.There was no patient injury.
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.
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 plastic housing on the anvil side of the instrument was disengaged from the anvil.The sulu was observed to be partially applied with the interlock engaged and microscopic examination confirmed no knife blade damage.It was reported that the instrument did not fire and the device component was disengaged.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The issue of disengaged housing may occur from excessive manipulation or rough handling of the instrument.Rough handling may be a result of user pulling on the handle to manipulate the device location or open the device without using the release button.The issue related to firing concern may occur if the firing stroke is not complete and the firing knob is not fully retracted after firing or if the instrument is applied against an excessive amount of tissue during the clinical ap plication.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: to open the instrument by pushing in on the black release button on the cartridge fork lever handle (located at the end of the instrument).The instrument should not be used on tissue such as liver or spleen where compressibility is such that closure of the instrument would be destructive.Tissue thickness should be carefully evaluated before firing any stapler.If the tissue can not comfortably compress to the specified minimum requirement, or compresses to less than this requirement, the tissue may be too thick or too thin for the selected staple size.Do not rotate the firing knob during firing.Rotating the knob during firing may cause damage and possible instrument malfunction.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: 23891372
• Report Number: 2647580-2025-03870
• Device Sequence Number: 5318916
• Product Code: GAG
• UDI-Device Identifier: 10884523007268
• UDI-Public: (01)10884523007268(17)290430(10)P4E0896(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221013
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2026

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: P4E0896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 03/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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