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

Model Number	SIGMRET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: egia45avm, egia45avm egia 45 artic vasc med sulu (lot#: unknown), sigphandle, sig power sigphandle handle (serial#: (b)(6), sigadaptxl, sig power sigadaptxl linear xl adapter (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 during a laparoscopic radical nephrectomy, the reload was fired across the hilum of the kidney.The powered stapler fully fired, but it would not retract and could not be opened.The handle was removed and reinstalled into the adapter, as well as fully rebooted while on the adapter, but the knife would still not retract.The manual retraction tool was used on the adapter by inserting it into the middle hole and turning it clockwise.The tool only turned a short way until it stopped.It could turn counterclockwise but would come to a stop when turning clockwise.The knife blade did not appear to retract at all.The manual retraction tool broke when trying to apply additional force to the middle hole.There was no room to insert another stapler and staple around the stuck reload to remove it.With no other options, the surgeon decided to convert to open.Additional dissection was done t o gain space around the hilum near the vena cava.Eventually enough room was obtained to allow for suture ligation, and the stapler could be cut free from the tissue.Surgical time was extended.
Event or Problem Description
According to the reporter, during a laparoscopic hand-assisted radical nephrectomy, the reload was fired across the hilum of the kidney.The powered stapler fully fired, but it would not retract and could not be opened.The handle was removed and reinstalled into the adapter, as well as fully rebooted while on the adapter, but the knife would still not retract.The manual retraction tool was used on the adapter by inserting it into the middle hole and turning it clockwise.The tool only turned a short way until it stopped.It could turn counterclockwise but would come to a stop when turning clockwise.The knife blade did not appear to retract at all.The manual retraction tool broke when trying to apply additional force to the middle hole.There was no room to insert another stapler and staple around the stuck reload to remove it.With no other options, the surgeon decided to convert to open.Additional dissection was done to gain space around the hilum near the vena cava.Eventually enough room was obtained to allow for suture ligation, and the stapler could be cut free from the tissue.Surgical time was extended by two hours.
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.

• 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: 22465550
• Report Number: 1219930-2025-02895
• Device Sequence Number: 17167994
• Product Code: GDW
• UDI-Device Identifier: 10884521543881
• UDI-Public: 10884521543881
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: SIGMRET
• Device Catalogue Number: SIGMRET
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown