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

Model Number	SIGPHANDLE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: sigcirxl, sigcirxl signia circ adapt x lng length (serial#(b)(6)); 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.
Event or Problem Description
It was reported that during an open colostomy reversal procedure at the anastomosis, the device was involved in a product issue reported as unknown for the handle.Surgical time was extended, and an anastomosis issue required resection and re-stapling at the anastomosis site with creation of a second anastomosis.A shorter colon length was reported.

• 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: 50854490
• Report Number: 1219930-2026-05856
• Device Sequence Number: 21320579
• Product Code: GDW
• UDI-Device Identifier: 10884521543782
• UDI-Public: (01)10884521543782(11)260303(20)06
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: SIGPHANDLE
• Device Catalogue Number: SIGPHANDLE
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2026
• 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
• Patient Sex: Unknown