MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIGTRSB45AMT
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic gastric bypass, when creating a gastric pouch, when firing, the reload was broken as it had firing issue.Another reload was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
D10.Concomitant medical products: sigphandle sig power sigphandle handle (serial unknown); unk-sigadapt unknown signia egia adapter (serial 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
D10 concomitant products: sigphandle sig power sigphandle handle(serial#:unknown), sigadaptxl, sig power sigadaptxl linear xl adapter (serial#:unknown) additional information: b5, d10, g3, h6 (fdr - c16) 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
According to the reporter, during a laparoscopic gastric bypass, when creating a gastric pouch, when firing, it had a firing issue.Another reload was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the distal suture end of the anvil was released.The distal cartridge suture was intact and the reload was unfired.Functionally, the reload was loaded into a representative instrument and was clamped and unclamped without difficulty.It was reported that there was a misfire issue.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of distal anvil suture released.The most likely cause could not be established from the information available.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 LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21313454
• Report Number: 1219930-2025-00609
• Device Sequence Number: 8151104
• Product Code: GDW
• UDI-Device Identifier: 10884521717602
• UDI-Public: 10884521717602
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2025

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: SIGTRSB45AMT
• Device Catalogue Number: SIGTRSB45AMT
• Device Lot Number: N3M1665Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 02/06/2025; 04/11/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/19/2025; 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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.; SEE H11.
• Patient Sex: Unknown