MAUDE Adverse Event Report: COVIDIEN GIA; STAPLER, SURGICAL

Model Number	GIA8048L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	12/10/2025
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
It was reported that during an open oesophagectomy, the device did not fire completely to the distal end while resecting the body part of the stomach.Suturing was performed as a staple line replacement.
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 noted the loading unit was partially applied.The interlock was engaged.Microscopic inspection noted no knife blade damage.Staple pushers were flush with the loading unit.Functionally, a representative instrument was used.The sulu (single use loading unit) was reset and loaded into the test 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.It was reported that there was an incomplete staple line.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 is not complete and the firing knob is not fully retracted after firing or if the instrument is applied against an excessive amount of tissue during the clinical application.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: 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 also 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; 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: 23823925
• Report Number: 2647580-2025-03756
• Device Sequence Number: 9974129
• Product Code: GAG
• UDI-Device Identifier: 10884523007275
• UDI-Public: (01)10884523007275(17)300131(10)P5B0613(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/11/2026

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 Model Number: GIA8048L
• Device Catalogue Number: GIA8048L
• Device Lot Number: P5B0613
• 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: 12/13/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown