MAUDE Adverse Event Report: Covidien LP Endo GIA Ultra; Stapler, surgical

Model Number	EGIAUSTND
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Misfire of the stapler.

• Brand Name: Endo GIA Ultra
• Common Device Name: Stapler, surgical
• Manufacturer (Section D): Covidien LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 50802742
• Report Number: 50802742
• Device Sequence Number: 10575949
• Product Code: GAG
• UDI-Device Identifier: 10884523003543
• UDI-Public: (01)10884523003543
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/31/2026
• Report Date (Section F): 08/31/2026

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
• Device Model Number: EGIAUSTND
• Device Lot Number: P6F1042
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 179 LB
• Date Report Sent to FDA: 08/31/2026