MAUDE Adverse Event Report: COVIDIEN GIA; STAPLER, SURGICAL

Model Number	GIA8038L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on post operative laparoscopic left hemicolectomy converted to open which occurred august 18, 2025, the staple line leaked the contents being held by the tissue, and the leak was discovered post-operatively.The procedure involved a colonic resection with side-to-side colo-colonic anastomosis and small bowel mass resection.Initially, a point of transection was selected just distal to the left middle colic artery, and a gia 80 mm loading unit was used to divide the colon.A side-to-side isoperistaltic colo-colonic anastomosis was then created using a gia 75 mm stapler, with the staple line and suture lines oversewn using 3-0 silk in a lembert stitch to reinforce the anastomosis.The small bowel mass, located in the serosa, was resected by transecting the bowel both proximally and distally to the mass with the gia 75 mm stapler.Another side-to-side isoperistaltic anastomosis was created, and the enterotomy was closed with 4-0 pds sutures, with the suture and staple lines oversewn with 3-0 silk sutures.The fascia was closed with running 1 pds sutures, and the skin was closed with staples.The patient experienced a life-threatening event due to the staple line leak and required extended hospitalization.
Additional Manufacturer Narrative
D10 concomitant products: gia8038s, gia8038s gia 80-3.8sgl use reload stap (lot#:unknown).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: b3, b5, g3 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 on post operative laparoscopic left hemicolectomy converted to open which occurred on (b)(6) 2025, the staple line leaked the contents being held by the tissue.The leak was discovered few days later post-operatively.The procedure involved a colonic resection with side-to-side colo-colonic anastomosis and small bowel mass resection.Initially, a point of transection was selected just distal to the left middle colic artery, and a gia 80 mm loading unit was used to divide the colon.A side-to-side isoperistaltic colo-colonic anastomosis was then created using a gia 75 mm stapler, with the staple line and suture lines oversewn using 3-0 silk in a lembert stitch to reinforce the anastomosis.The small bowel mass, located in the serosa, was resected by transecting the bowel both proximally and distally to the mass with the gia 75 mm stapler.Another side-to-side isoperistaltic anastomosis was created, and the enterotomy was closed with 4-0 pds sutures, with the suture and staple lines oversewn with 3-0 silk sutures.The fascia was closed with running 1 pds sutures, and the skin was closed with staples.The patient experienced a life-threatening even t due to the staple line leak and required extended hospitalization.

• 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: 23800598
• Report Number: 2647580-2025-03723
• Device Sequence Number: 15800152
• Product Code: GAG
• UDI-Device Identifier: 10884523007251
• UDI-Public: (01)10884523007251(17)300131(10)P5B0607(20)02
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GIA8038L
• Device Catalogue Number: GIA8038L
• Device Lot Number: P5B0607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/07/2026
• Date Device Manufactured: 02/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 100 KG