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

Model Number	SIGPHANDLE-RFB
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Insufficient Information (4580)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sigcirxl, sigcirxl signia circ adapt x lng length (serial#: (b)(6)).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 intraoperatively, the stapler was stuck on the home screen even after connecting the anvil and approximating the anvil to the reload.The stapler would not begin the percentage portion of the device.The user re-extended the spike to 100% and this issue did not persist.After firing though, there was no issue with the staple line, yet there was a tear in the bowel which was noticed during leak test.The surgery was modified to resolve the issue.
Event or Problem Description
According to the reporter, intraoperatively, the stapler was stuck on the home screen even after connecting the anvil and approximating the anvil to the reload.The stapler would not begin the percentage portion of the device.The user re-extended the spike to 100% and this issue did not persist.After firing though, there was no issue with the staple line, yet there was a tear in the bowel which was noticed during leak test.Staple line was oversewn.Surgical time was extended as a result of this event.The bowel tear was not related to the device.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 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 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.

• 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: 25012613
• Report Number: 1219930-2026-02789
• Device Sequence Number: 9655565
• Product Code: GDW
• UDI-Device Identifier: 10884521797437
• UDI-Public: (01)10884521797437(11)221229(10)C22AAM0630
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K201672
• 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): 05/12/2026

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: SIGPHANDLE-RFB
• Device Catalogue Number: SIGPHANDLE-RFB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2022
• 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 Age: 66 YR
• Patient Sex: Female