MAUDE Adverse Event Report: COVIDIEN SURGICAL SIGNIA; STAPLER, SURGICAL

Model Number	SIGCIRXL
Medical Device Problem Codes	Device Slipped (1584); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a robot-assisted low anterior resection, the powered circular stapler displayed all green indicators during assembly.The device was inserted, the spike was extended to the maximum position, and the anvil was connected without issue.When the first assistant attempted to close the device to apply it to the very low rectum, it did not fully close, and a yellow adapter general error code appeared on the screen.The team attempted to open and close the device three additional times; however, the issue persisted.The surgeon then removed the circular stapler and replaced it with a manual circular stapler, which was fired without issue.No patient injury was reported.
Additional Manufacturer Narrative
D10 concomitant products: sigphandle sig power sigphandle handle - (serial#unknown); unk peea reload unknown powered eea reload - (lot#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: STAPLER, SURGICAL
• 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: 25688906
• Report Number: 1219930-2026-04243
• Device Sequence Number: 21265154
• Product Code: GAG
• UDI-Device Identifier: 10884521845497
• UDI-Public: (01)10884521845497(11)251208
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K240881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: SIGCIRXL
• Device Catalogue Number: SIGCIRXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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