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

Model Number	SIGTRSB45AMT
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a thoracoscopic wedge resection of the lung, after the nurse loaded the handle with the reload for the surgeon, the reload magazine fell off the handle.A second reload was loaded into the same handle.The surgeon placed the fully articulated reload on the lung tissue.The green button was pressed, and the instrument was fully fired, and the staples were placed in the tissue.Then, the black retraction button could not be retracted to open the instrument.The jaws locked and could not be removed from the tissue.The surgical procedure was converted into an open surgery, and the surgical time was extended by more than 60 minutes.The surgeon placed another stapler with a 45 mm purple loading unit distal to the blocked loading unit and then released the instrument.The blocked magazine was then removed from the site.The incision had to be widened considerably in the thoracic region.
Additional Manufacturer Narrative
D10 concomitant products: egiaustnd endogia ultra univ std stap - (lot#p4m0944); sigtrsb45amt 45mm med thk reinforced rel - (lot#n3c0737y) 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: d3 (mfr name and address), d4 (udi#), d9, g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the staples were placed in the tissue and the black retraction button could not be retracted.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with 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.
Additional Manufacturer Narrative
Correction: b3.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22056016
• Report Number: 1219930-2025-02216
• Device Sequence Number: 14483882
• Product Code: GDW
• UDI-Device Identifier: 10884521717602
• UDI-Public: (01)10884521717602(17)260228(10)N3C0737Y(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173270
• 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,Followup
• Report Date (Section B): 08/19/2025

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 Expiration Date: 02/28/2026
• Device Model Number: SIGTRSB45AMT
• Device Catalogue Number: SIGTRSB45AMT
• Device Lot Number: N3C0737Y
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 08/19/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/08/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown