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

Model Number	EGIAADAPT
Medical Device Problem Codes	Failure to Fire (2610); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic sigmoidectomy, after the device was assembled, and when entered i the cavity it seemed that it was soft.The account then turned on and it didn't comply all the commands and didn't release the staple.When it was done the attempt to change the reload was also made, but it didn't open and crashed.The account tried a lot to get the reload, but it broke in the staple.The surgeon then used another device to resolve the issue in order to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted there was a broken piece of a reload adapter stuck in the distal end of the adapter and the adapter had 26 of 50 procedures remaining.It was reported that the device did not fire, and the device was difficult to unload.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the firing rod tip was damaged.The product analysis noted evidence that the device was not used as intended.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, during laparoscopic sigmoidectomy, after the device was assembled, and when entered i the cavity it seemed that it was soft.The account then turned on and it didn't comply all the commands and didn't release the staple.When it was done the attempt to change the reload was also made, but it didn't open and crashed.The reload could not be removed from the adapter, the account tried a lot to get the reload, but it broke in the staple.The surgeon then used another device to resolve the issue in order to complete the case.There was no patient injury.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12293982
• Report Number: 1219930-2021-03233
• Device Sequence Number: 4724891
• Product Code: GDW
• UDI-Device Identifier: 10884521142800
• UDI-Public: 10884521142800
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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: EGIAADAPT
• Device Catalogue Number: EGIAADAPT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown