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

Model Number	SIGADAPTSHORT
Medical Device Problem Codes	Difficult to Open or Close (2921); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, pre-operatively, the device functioned normally up to the lcd (liquid crystal display) screen guiding cartridge connection, but after the cartridge was connected, the opening and closing operation could not be performed and upon restarting, the cartridge moved left and right automatically and then stopped, remaining unable to open or close.A new adapter was used to resolve the issue.There was no patient involved.
Additional Manufacturer Narrative
D10 - concomitant products: sigphandle, sig power sigphandle handle, (s# unknown) sigpshell, sig power sigpshell control shell, (s# unknown) unknown egia su, unknown endo gia sulu, (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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functionally, a r epresentative smart reload was attached to the adapter but was unable to be recognized.The adapter was then disassembled and it was determined that the proximal flex cable was damaged.This would prevent the reload clamp test from being performed.If a signia system is green key reset while a unrecognized reload is connected, uncontrolled articulation will be observed.It was reported that after the cartridge was connected, the opening and closing operation could not be performed and upon restarting, the cartridge moved left and right automatically and then stopped, remaining unable to open or close.The reported issues were confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition of articulation mechanism not in home position that has no relationship to the reported condition.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.The instructions included with this device provide the following guidance: if a stapling reload is difficult to unload, center the reload and fully open the jaws by manually controlling the toggle or press and hold the up control button for two seconds.The articulation will center and the jaws of the reload will fully open.Reattempt to unload the stapling reload by pressing the blue unload switch back toward the power handle, twist the reload counterclockwise 45 degrees and remove the reload from the shaft of the adapter.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: 24217876
• Report Number: 1219930-2026-00575
• Device Sequence Number: 15510061
• Product Code: GDW
• UDI-Device Identifier: 10884521543829
• UDI-Public: (01)10884521543829(11)240917
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: SIGADAPTSHORT
• Device Catalogue Number: SIGADAPTSHORT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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
• Patient Sex: Unknown