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

Model Number	SIG60CTAMT
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic bronchoscopy video-assisted thoracoscopic surgery (vats) procedure, the instrument did not fire.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10 concomitant product: egiaustnd, egiaustnd endogia ultra univ std stap, (lot number: p5c1217) 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 a laparoscopic bronchoscopy video-assisted thoracoscopic surgery (vats), the instrument did not fire.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5, e4 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: 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 staple cartridge was pre-fired and engaged in interlock.The jaws of the reload were clamped.Functional testing found that he reload jaws were manually opened.The reload was loaded into a representative instrument.The jaws were clamped and unclamped repeatedly without difficulty.While clamping the clamping mechanism was observed to be deformed.The interlock was overridden and was applied to test media.All staples were placed and test media was cleanly transected.The reload interlock was tested and found to function properly.It was reported that the instrument did not fire.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur under the following conditions.The shipping wedge has been removed or is no longer fully seated in the metal channel prior to loading.The shipping wedge has been removed or is no longer fully seated in the metal channel and the jaws have been manually clamped prior to loading.The shipping wedge has been removed or is no longer fully seated in the metal channel and an attempt has been made to load a loading unit with the instrument firing rod exte nded.Please note that the yellow shipping wedge must be securely in place during instrument loading.The shipping wedge ensures that the single use loading unit (sulu) engages in the instrument to facilitate clamping and unclamping.Do not attempt to remove the s hipping wedge until the sulu is loaded into the instrument.Ensure that the black return knob on the instrument is pulled back completely and the articulation lever is neutral (0° relative) to the instrument.Cycle the instrument to confirm proper loading of the reload.To do so, squeeze the handle once to close the jaws of the reload.Push the black loop handle all of the way forward or pull back on the black return knob and confirm that the reload jaws open fully.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: always select a reload with the appropriate staple size for the tissue thickness.Overly thick or thin tissue may result in unacceptable staple formation.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.Failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/or leakage.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 SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23550089
• Report Number: 1219930-2025-05302
• Device Sequence Number: 18585695
• Product Code: GDW
• UDI-Device Identifier: 10884521543683
• UDI-Public: (01)10884521543683(17)281130(10)N3M1716Y(20)03
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160176
• 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,Followup
• Report Date (Section B): 01/05/2026

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: SIG60CTAMT
• Device Catalogue Number: SIG60CTAMT
• Device Lot Number: N3M1716Y
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/30/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/13/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 100 KG