MAUDE Adverse Event Report: COVIDIEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIG60AMT
Medical Device Problem Codes	Retraction Problem (1536); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic procedure, the device partially fired, became lodged on the specimen, and became stuck, requiring removal by cutting it out of the patient¿s body.These complications led to an extended surgical time.The issue was resolved by resecting and re-stapling using a new reload, pli40 medtronic's initial evaluation of the incident device found that several millimeters of material were found to be sheared from the distal end of the firing rod.Pli50: medtronic's initial evaluation of the incident device found , the incomplete retraction could be traced to the damage to the firing rod of returned adapter.Pli60: medtronic's initial evaluation of the incident device found , the incomplete retraction could be traced to the damage to the firing rod of returned adapter.Pli70: medtronic's initial evaluation of the incident device found , the incomplete retraction could be traced to the damage to the firing rod of returned adapter.
Additional Manufacturer Narrative
D10 concomitant products : egia60amt - egia60amt egia 60 artic med thick sulu - lot# unknown sigphandle - sig power sigphandle handle - sn: unknown sigadaptstnd - sig power sigadaptstnd linear adapter - sn: (b)(6); sigadaptshort - sig power sigadaptshort lin short adapt - sn: (b)(6); sig30ctav - tri 2.0 sig30ctav (b)(4) ct vsclr 12mm - lot# n4e1903y sig30ctav - tri 2.0 sig30ctav (b)(4) ct vsclr 12mm - lot# n4e1903y.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: g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.No information re garding the specific customer issue that occurred with the device was available.Upon examination of the sample, it was found that the retraction was incomplete.The most likely cause was not traced to the device.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.

• Brand Name: TRI-STAPLE 2.0
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 24724057
• Report Number: 2647580-2026-00858
• Device Sequence Number: 16035134
• Product Code: GDW
• UDI-Device Identifier: 10884521808973
• UDI-Public: (01)10884521808973(17)261130(10)P1M0570(20)01
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K202864
• 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): 07/09/2026

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: SIG60AMT
• Device Catalogue Number: SIG60AMT
• Device Lot Number: P1M0570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown