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

Model Number	SIGADAPTSHORT
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a video-assisted thoracoscopic surgery, after stapling the parenchymal tissue, the jaws of the reload could no longer be opened, and the knife could not be retracted.The adapter was removed from the powered handle, and an attempt was made to manually open the reload with a retracting tool, but without success.The reload could not be disconnected from the adapter.A new adapter and a new reload were used to excise the defective reload.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: egia45amt, egia45amt egia 45 artic med thick sulu, (lot number: n5f1941y) sigphandle, sig power sigphandle handle, (serial number: (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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the 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.It was reported that the instrument was locked on tissue and difficult to unload.The reported issues were confirmed.The most likely cause was of the damage to the tip of the firing rod could not be established.The evaluation detected an unreported condition: universal asynchronous receiver-transmitter (uart) error.Functional testing found that there was a universal asynchronous receiver-transmitter (uart) communications error in the data saved to the system.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.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 reload unload button 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: 23321072
• Report Number: 1219930-2025-04747
• Device Sequence Number: 16105075
• Product Code: GDW
• UDI-Device Identifier: 10884521543829
• UDI-Public: (01)10884521543829(11)240729
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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
• Date Returned to Manufacturer: 10/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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: Unknown