MAUDE Adverse Event Report: COVIDIEN SURGICAL GIA; STAPLER, SURGICAL

Model Number	GIA60MTS
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the reporter during a procedure, the device partially fired.
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 of the instrument noted no abnormalities.The single use loading unit (sulu) was partially applied.The interlock was engaged.Microscopic inspection of the knife blade displayed no damage.The sulu was dipped.Functional testing noted that the sulu 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 partial firing occurred.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the firing stroke was not completed and the firing knob was not fully retracted after firing or if the instrument was applied against an excessive amount of tissue during the clinical application.If the firing knob was not fully retracted, difficulty in unloading the loading unit may be experienced, and may prevent further loading from occurring.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 SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22690016
• Report Number: 1219930-2025-03420
• Device Sequence Number: 8255348
• Product Code: GAG
• UDI-Device Identifier: 10884521723436
• UDI-Public: (01)10884521723436(17)251231(10)H4B2057URY(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K221006
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: 12/31/2025
• Device Model Number: GIA60MTS
• Device Catalogue Number: GIA60MTS
• Device Lot Number: H4B2057URY
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• 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