MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN GIA; STAPLER, SURGICAL

Model Number	GIA60MTC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a subtotal gastrectomy and open colectomy procedure, after firing the stapler, the cartridge broke.It was then removed, washed with saline, and a second cartridge was then securely loaded without 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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the loading unit was not broken.Functional evaluation found no notable condition related to reported condition.It was reported that the instrument broke.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: partially fired.Visual inspection noted the loading unit was partially applied.The interlock was engaged.Microscopic inspection noted no knife blade damage.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 knife cut completely and cleanly and the remaining staple line was properly formed.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.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: 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.The appropriate tissue ranges for safe use and instructions for proper use of stapler were stated.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 LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20745665
• Report Number: 1219930-2024-05478
• Device Sequence Number: 20907268
• Product Code: GAG
• UDI-Device Identifier: 10884521723498
• UDI-Public: (01)10884521723498(17)270228(10)N2C0387UY(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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 Model Number: GIA60MTC
• Device Catalogue Number: GIA60MTC
• Device Lot Number: N2C0387UY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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