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

Model Number	GIA60MTS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ileus situation involving a hartmann procedure, an ileostomy was created.The device was initially used for the transection of the transverse colon.A new reload was utilized with the instrument for the transection of the ileum.The surgeon observed a 0.5cm leak in the middle of the staple line of the transverse colon.The staple line leaked the contents contained within the tissue.To address the issue, the affected area was resected and re-stapled.
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 that the opened reload interlock was reset.The reloads were loaded into the instruments.The reloads unloaded and loaded repeatedly without difficulty.The instruments and reloads were applied to test media with acceptable results.The knives cut completely and cleanly and the staple line was properly formed.The firing knobs could be advanced and retracted without any hang-ups.It was reported that the staple line content leak.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 ileus situation involving a hartmann procedure, an ileostomy was created.The device was initially used for the transection of the transverse colon.A new reload was utilized with the instrument for the transection of the ileum.The surgeon observed a 0.5 cm leak in the middle of the staple line of the transverse colon.The staple line leaked the contents contained within the tissue.To address the issue, the affected area was resected and re-stapled.Product was received without accompanying information.

• 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: 22176388
• Report Number: 1219930-2025-02489
• Device Sequence Number: 7799119
• Product Code: GAG
• UDI-Device Identifier: 10884521723436
• UDI-Public: 10884521723436
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: GIA60MTS
• Device Catalogue Number: GIA60MTS
• Device Lot Number: N4G2148UY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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