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

Model Number	SIGCIRXL
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sigcir31mt ts 2.0 sigcir31mt circ.31mm med/thick - (lot#n5j1301uy); sigphandle sig power sigphandle handle - (serial#c25aab0844); sigpshell sig power sigpshell control shell.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 robotic laparoscopic sigmoidectomy, after the powered circular stapler completed its stapling and following firing sequence and before tapping up on the toggle, yellow swim lanes two for adapter and three for reload turned yellow with a warning triangle.The stapler prompted the surgeon to open the spike, and nothing happened, but the spike was fully extended.The surgeon extended the spike and the middle yellow swimlane turned green but the last yellow swim lane remained yellow.The surgeon proceeded to pull the stapler out, and it came out without the anvil connected to the spike.The surgeon had to manually pull the anvil from the patient's rectum.Upon inspection, donuts were complete, and the leak test was negative.The surgical time was extended by 25 minutes.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9 (return date), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.The electronic device-use logs were also provided.A visual inspection of the returned photo noted a signia circular adapter.An initial visual inspection of the returned adapter noted no abnormalities.Functionally, the adapter was connected to the gen2 adapter black box running gen2 acc software, and the strain gauge was responsive.The adapter was connected to a representative clamshell and a signia handle running signia circular testing software.The signia handle displayed the surgical site extraction screen.A four-key reset was performed and the adapter calibrated correctly.The adapter was able to be connected to the t44594 test fixture and fired without issue.After firing, the adapter was reconnected to the gen2 acc software and no new errors appeared.A review of the system logs showed that the adapter was returned in the surgical site extraction recovery state.The adapter had 34 of 50 procedures remaining.It was reported that the anvil disengaged.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the reload had a yellow swim lane.The reported issue was confirmed.The most likely cause was not traced to this device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: 24558163
• Report Number: 1219930-2026-01564
• Device Sequence Number: 8828325
• Product Code: GAG
• UDI-Device Identifier: 10884521845497
• UDI-Public: (01)10884521845497(11)241204
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/29/2026

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: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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: Female
• Patient Weight: 64 KG