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

Model Number	SIGTRSB45AXT
Medical Device Problem Codes	Entrapment of Device (1212); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Abdominal Pain (1685); Laceration(s) (1946)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: sigadaptstnd sig power sigadaptstnd linear adapter - (serial#unknown); sigphandle sig power sigphandle handle -(serial#(b)(6); sigsbchgr sig power sigsbchgr one -bay charger -(serial#(b)(6) 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 minimally invasive stapled abdominal repair (misar) abdominal diastasis procedure, after firing, it was difficult to straighten the device, and the jaws of the reload did not open despite all the attempts to reset the device.A screwdriver was used, but it did not resolve the issue.The surgery was converted to an open surgery, and suturing was done to resolve the issue.The device was removed by making a cut with scissors.Post-operatively, the patient had acute abdominal pain and took medication and pain relief therapy.The charger was working intermittently.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the device partially fired with the interlock engaged.The jaws were clamped on tissue, and the i-beam advanced to the 1-centimeter (cm) mark.The distal sutures on both the anvil and cartridge sides remained anchored, while the proximal end of the reload adapter was found broken.It was reported that after firing, the jaws of the reload did not open despite all the attempts to reset the device.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur due to over flexure of the reload while attached to the instrument, or when the firing handle has not been completely cycled.It was also reported that after firing, it was difficult to straighten the device.The reported issue could not be confirmed.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.The instructions included with this device provide the following guidance: 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 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22374593
• Report Number: 1219930-2025-02791
• Device Sequence Number: 4413469
• Product Code: GDW
• UDI-Device Identifier: 10884521717619
• UDI-Public: 10884521717619
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 09/22/2025

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 Model Number: SIGTRSB45AXT
• Device Catalogue Number: SIGTRSB45AXT
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female