MAUDE Adverse Event Report: COVIDIEN SURGICAL SIGNIA; STAPLE, IMPLANTABLE

Model Number	SIGADAPTSTND
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Misfire (2532); Calibration Problem (2890); Human-Device Interface Problem (2949); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparotomy liver resection, the first firing went well.The second reload advanced only halfway and stopped working, resulting in a partial fire.Attempts to deangulate and retract the reload were unsuccessful, and rebooting the powered stapler made a noise but did not realign or retract the reload.The reload appeared broken at the articulation junction.The light-emitting diode (led) screen showing a yellow arrow to the right.The scrub nurse confirmed that attaching and testing the connection was performed as usual, and the surgeon was able to press the activation button and activate the device as usual.The surgeon did not check the led screen for tissue thickness.To resolve the issue, the surgeon cut around the liver to remove the stuck reload, opened a manual stapler and a new reload, and used clips and sutures as needed to complete the procedure.The nurse was unable to remove the reload from the adapter due to persistent angulation.
Additional Manufacturer Narrative
D10 concomitant products: 030457, 030457 endo gia r/or 60 2.5mm x6, (lot number: unknown) sigphandle, sig power sigphandle handle, (serial number: 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.

• Brand Name: SIGNIA
• 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: 24780879
• Report Number: 1219930-2026-02195
• Device Sequence Number: 21304443
• Product Code: GDW
• UDI-Device Identifier: 10884521543805
• UDI-Public: (01)10884521543805(11)210809
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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: SIGADAPTSTND
• Device Catalogue Number: SIGADAPTSTND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown