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

Model Number	SIGADAPTXL
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Retraction Problem (1536); Device Displays Incorrect Message (2591); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10: concomitant products: sigphandle - sig power sigphandle handle - sn: (b)(6), sigtrsb60axt - sigtrsb60axt 60mm xtr thk reinforced rel - lot#: n5j1376y.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 an (hpb) hepatobiliopancreatic, distal pancreatectomy and splenectomy surgical procedure, an undefined adapter error, issues after firing, and difficulty removing the device from the patient.The yellow caution error appeared on the screen with an adapter error and an arrow indicating to remove the reload while the device was still clamped on tissue.This occurred during firing while attempting to retract the knife blade, which moved forward and backward about 2 cm.Disconnecting the handle did not resolve the issue.A reset of the power handle ultimately allowed retraction of the knife blade and removal of the stapler from the tissue.No patient complications have been reported as a result of this event.From sr-609032065- duplicate of pe 709009542.

• 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: 24871420
• Report Number: 1219930-2026-02449
• Device Sequence Number: 15953060
• Product Code: GDW
• UDI-Device Identifier: 10884521543812
• UDI-Public: (01)10884521543812(11)241113
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: SIGADAPTXL
• Device Catalogue Number: SIGADAPTXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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