MAUDE Adverse Event Report: Covidien Surgical Signia; STAPLE, IMPLANTABLE

Model Number	SIGADAPTSTND
Medical Device Problem Codes	Entrapment of Device (1212); Calibration Problem (2890)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a robot-assisted rectal resection, when at the rectum, when the cartridge was removed, a warning symbol was displayed.The adapter swimlane was black with green outline.It was noted that it was unable to detach the jaw from the tissue.The issue was managed with an electric scalpel, and the procedure was converted to laparotomy in order to take out the cartridge.Also, additional resection was performed on the oral side of the suture site, resulting in a prolonged operative time for more than 30 minutes.
Additional Manufacturer Narrative
D10 concomitant product: egia45amt, egia45amt egia 45 artic med thick sulu, (lot #p5f0977); sigphandle, sig power sigphandle handle, (serial #unknown); sigpshell, sig power sigpshell control shell, (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.

• 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--439 ; +1(800)646-4633
• MDR Report Key: 50310877
• Report Number: 1219930-2026-05201
• Device Sequence Number: 21025245
• Product Code: GDW
• UDI-Device Identifier: 10884521543805
• UDI-Public: (01)10884521543805(11)250604(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: SIGADAPTSTND
• Device Catalogue Number: SIGADAPTSTND
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 06/04/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female