BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, CROSSFIRE 2 CONSOLE

    MDR report key: 16311160 · Received February 7, 2023

    Report

    Report Number
    0002936485-2023-00086
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 14, 2023
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    UDI-DI
    07613327058109
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: *UNIT WAS REPAIED RECENTLY ON RMA 3800162 AND WHEN UNIT WAS PUT BACK INTO ROTATION IT SPARKEDF AND BLEW OUT SOME FUSES AND NEED TO BE SENT BACK IN, (B)(4). THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE ROOT CAUSE IS THE RF BOARD. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A THERMAL EVENT AND SPARKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A THERMAL EVENT AND SPARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226291 PKG, CROSSFIRE 2 CONSOLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 0475100000 07613327058109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown