MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIA45AV
Medical Device Problem Codes	Misfire (2532); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The involved device was not returned.Visual inspection noted the observed failure of the inability to remove the reload was not caused by this device.Functionally, the reload was straightened and was able to be removed with ease, was loaded onto the returned adapter and was able to clamp and articulate without issues.The reload was then able to be removed from the adapter without issues, was connected to a manual handle and the interlock was overridden, and was fired over test media and the remaining staples were placed.It was reported that the device was difficult to unload.The reported issue was confirmed.The most likely cause was not traced to the device.This issue may occur due to the adapter's articulation mechanism not being in its home position.The evaluation detected an unreported condition: the device was found to be partially fired.The most likely cause could not be established from the information available.This issue may occur if the firing button had been partially compressed and then the open button was pressed after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the reload from firing a second time.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to a procedure, the sales representative cannot remove reload from adapter.No patient involvement.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 11369098
• Report Number: 1219930-2021-00731
• Device Sequence Number: 4125461
• Product Code: GDW
• UDI-Device Identifier: 10884523003161
• UDI-Public: 10884523003161
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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: EGIA45AV
• Device Catalogue Number: EGIA45AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1