MAUDE Adverse Event Report: COVIDIEN GIA; STAPLER, SURGICAL

Model Number	GIA10038S
Medical Device Problem Codes	Failure to Align (2522); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, in an open pancreaticoduodenectomy, during gastric body transection, the two halves of the stapler would not join and lock into place as usual at the hinge pin.The staple jaws could not be closed.The packaging of the device was also damaged.The device was not used on the patient.Another device was used to complete the case.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.Functionally, the sulu (single use loading unit) was reset and loaded into the instrument.The sulu unloaded and loaded repeatedly without difficulty.The sulu and instrument were applied to test media with acceptable results.The firing knob advanced and retracted without difficulty.The knife cut completely and cleanly.The remaining staples deployed and formed properly.It was reported that during gastric body transection, the two halves of the stapler would not join and lock into place as usual at the hinge pin.The staple jaws could not be closed.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The evaluation detected an unreported condition of partially applied that has no relationship to the reported condition.The product analysis noted evidence that the device was not used as intended.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 remove the sulu, separate the instrument halves.Holding the cartridge-half of the instrument, grasp the proximal end of the sulu tabs and pull up and out to remove the sulu from the instrument.To place a new sulu into the instrument, hold the sulu by the proximal end tabs and insert into the cartridge fork at a 30 to 45 degree angle from the distal end down until the unit snaps into place.Remove shipping wedge after sulu is fully loaded.Sulu will ¿float¿ up and down in final loaded position.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: 23954682
• Report Number: 2647580-2026-00019
• Device Sequence Number: 5610968
• Product Code: GAG
• UDI-Device Identifier: 30884521031672
• UDI-Public: (01)30884521031672(17)260831(10)P1J1364S(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
• 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): 04/07/2026

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 Expiration Date: 08/31/2026
• Device Model Number: GIA10038S
• Device Catalogue Number: GIA10038S
• Device Lot Number: P1J1364S
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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