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

Model Number	SIGSDS30CTVT
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921); Expulsion (2933)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter during a procedure, there was no issue during the first and second firing, but at the time of loading for the third firing.The slight opening and closing did not operate accurately and the opening and closing operation was stiff.After completing the opening and closing check of the jaws, the blood vessel was approached and firing was attempted, but firing could not be performed.The tip side of the cartridge was opened and collected, the handle and cartridge were both replaced and when an approach was made again, the resection was performed without any problem.After the surgery the cartridge was checked and a slight/few pre-firings were found at the proximal side of the channel jaws.
Additional Manufacturer Narrative
D10 concomitant products: egiaushort, egiaushort endogia ultra univ sht stap (lot #: p4l0796).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: b5, g3 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 an upper lobe resection, there was no issue during the first and second firings, but at the time of loading for the third firing, the slight opening and closing did not operate accurately, and the opening and closing operation was stiff.After completing the opening and closing check of the jaws, the blood vessel was approached and firing was attempted, but firing could not be performed.The tip side of the cartridge was opened and collected; the handle and cartridge were both replaced, and when an approach was made again, the resection was performed without any problem.After the surgery, the cartridge was checked, and a slight/few pre-firings were found at the proximal side of the channel jaws.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Func tional testing found that all staples were placed and test media was cleanly transected.The reload interlock was tested and found to function properly.It was reported that the instrument did not fire and the staple pre-fire.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the instrument firing handle had been partially compressed and released after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the reload from firing a second time by ceasing the placement of staples and tissue transection and prevent patient harm.It was also reported that the jaws did not close and open smoothly.The reported issues could not be 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.The instructions included with this device provide the following guidance: always inspect the tissue thickness and select an appropriate staple size prior to application of the endo gia¿ universal stapler.2.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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 an upper lobe resection, there was no issue during the first and second firings, but at the time of loading for the third firing, the slight opening and closing did not operate accurately, and the opening and closing operation was stiff.After completing the opening and closing check of the jaws, the blood vessel was approached and firing was attempted, but firing could not be performed.The tip side of the cartridge was opened and collected; the handle and cartridge were both replaced, and when an approach was made again, the resection was performed without any problem.After the surgery, the cartridge was checked, and a slight/few pre-firings were found at the proximal side of the channel jaws.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.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: 22903464
• Report Number: 1219930-2025-03735
• Device Sequence Number: 15431452
• Product Code: GDW
• UDI-Device Identifier: 10884521741881
• UDI-Public: (01)10884521741881(17)261130(10)N4M1714URY(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/21/2025

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: SIGSDS30CTVT
• Device Catalogue Number: SIGSDS30CTVT
• Device Lot Number: N4M1714URY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 09/22/2025; 10/03/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/19/2025; 10/07/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown