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

Model Number	SIGADAPTXL
Medical Device Problem Codes	Failure to Read Input Signal (1581); Vibration (1674); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: sigphandle, sig power sigphandle handle (serial#: unknown) sigtrsb60amt 60mm med thk reinforced rel (lot#: unknown) sigtrsb60amt 60mm med thk reinforced rel (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.
Event or Problem Description
It was reported that pre-operatively, while on preparation for use, the adapter did not take the reload, and after a new reload was inserted, the device started twitching and the guide rod began moving out on its own.The adapter still had 43 lives left to use.Asecond adapter had to be attached to complete the case and resolve the issue.There was no patient involved.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the firing rod was extended distally past home position by several inches.Damage to the j-hook slot of the firing rod was visible.The blue unload switch was stuck in the fully depressed position.Functionally, the blue unload switch could not be depressed.The adapter was connected to the gen2 adapter black box running gen2 acc software, and the strain gauge was responsive.The adapter had 41 of 50 procedures remaining.The adapter was connected to an rpa signia handle running v29.6 software, and the device calibrated correctly.The firing rod returned to home position.The device calibrated correctly.The blue unload switch returned to the home position.An rpa reload was attached to the adapter and was able to be loaded and unloaded without difficulty.The reload was able to be rotated and articulated in all directions without hang-ups or sluggishness.The adapter was able to be fired without any issues.After firing, the adapter was reconnected to the gen2 acc software, and no new errors appeared.The instrument did not rotate in an uncontrolled manner or experience excessive vibrations during testing.The adapter was partially disassembled, and damage to the j-hook and tip backer was found.It was reported that there was an uncontrolled articulation and the device was vibrating.The reported issues could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the device was difficult to load.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: 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: 24654826
• Report Number: 1219930-2026-01830
• Device Sequence Number: 6121600
• Product Code: GDW
• UDI-Device Identifier: 10884521543812
• UDI-Public: (01)10884521543812(11)250207
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• 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: SIGADAPTXL
• Device Catalogue Number: SIGADAPTXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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 NOTE ON H11
• Patient Sex: Unknown