MAUDE Adverse Event Report: COVIDIEN LP TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIG30AMT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Tri-staple 2.0 reload was loaded into the stapler by the tech.When the surgeon attempted to fire the stapler, nothing happened.Upon further inspection, the tech could see that the stapler had misfired.The patient unharmed.The staple load was then immediately removed from the sterile field.

• Brand Name: TRI-STAPLE 2.0
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15248514
• Report Number: 15248514
• Device Sequence Number: 6390277
• Product Code: GDW
• UDI-Device Identifier: 10884521543652
• UDI-Public: (01)10884521543652
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 08/11/2022
• Report Date (Section F): 08/11/2022

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: SIG30AMT
• Device Lot Number: N2CO465Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 08/11/2022