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

Model Number	SIGADAPTXL
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction

• 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: 50111721
• Report Number: 1219930-2026-04818
• Device Sequence Number: 10744291
• Product Code: GDW
• UDI-Device Identifier: 10884521543812
• UDI-Public: (01)10884521543812(11)240216
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 10/01/2026

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: SIGADAPTXL
• Device Catalogue Number: SIGADAPTXL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Female