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

Model Number	SIGLU60A
Medical Device Problem Codes	Failure to Read Input Signal (1581); Failure to Fire (2610)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic sleeve procedure, an issue occurred while attempting to transect the duodenum.The user first replaced the power handle and shell, then tried using the original loading unit.However, the stapler failed to fire thereload, the loading unit did not recognize.Subsequently, the staff replaced the loading unit with the original staple cartridge.This extended the surgical time by a few minutes.The loading unit and cartridge were recognized by the stapler, and the surgeon was able to fire the device successfully.
Additional Manufacturer Narrative
Additional information: b5 (event description) 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.
Additional Manufacturer Narrative
Correction: b5 additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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 laparoscopic sleeve procedure, while attempting to transect the duodenum.The user first replaced the power handle and shell, then tried using the original loading unit.However, the stapler failed to fire the reload due to the loading unit was not recognized.Subsequently, the staff replaced the loading unit with the original staple cartridge.This extended the surgical time by a few minutes.The loading unit and cartridge were recognized by the stapler, and the surgeon was able to fire the device successfully.
Additional Manufacturer Narrative
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 the laparoscopic sleeve procedure, an issue occurred while attempting to transect the duodenum.The user first replaced the power handle and shell, then tried using the original loading unit.However, the stapler failed to fire the reload.Subsequently, the staff replaced the loading unit with the original staple cartridge.This extended the surgical time by a few minutes.The loading unit and cartridge were recognized by the stapler, and the surgeon was able to fire the device successfully.
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 no abnormalities.Functional testing found that the loading unit was loaded onto a representative signia handle, clamshell, and adapter.The loading unit communication with the handle was verified and revealed that the returned loading unit had not been fired.A representative cartridge was inserted into the loading unit and recognized.The loading unit was applied to test media with proper staple formation and media transection.The handle correctly displayed that the loading unit had been fired one time.The representative cartridge was recognized as unfired.The handle was able to enter firing mode but engaged in firing.The handle displayed another loading unit firing but the cartridge was still recognized as unfired.The loading unit was attached to another representative signia handle, clamshell, adapter and cartridge but the issue persisted.It was reported that the loading unit was not recogni zed.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 24215779
• Report Number: 1219930-2026-00564
• Device Sequence Number: 15762560
• Product Code: GDW
• UDI-Device Identifier: 10884521543508
• UDI-Public: (01)10884521543508(17)300630(10)N5G1981Y(20)01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/08/2026

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: SIGLU60A
• Device Catalogue Number: SIGLU60A
• Device Lot Number: N5G1981Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 01/21/2026; 01/30/2026; 04/07/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 01/30/2026; 01/30/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female