BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUSH-BUTTON SMOKE EVAC. PENCIL, COATED

    MDR report key: 11961074 · Received June 8, 2021

    Report

    Report Number
    0001811755-2021-00772
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    April 13, 2021
    Report Date
    July 22, 2021
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GEI
    PMA / PMN Number
    K143145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED CATALOG NUMBER. THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE WAS DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH REPORT MW 5101090 THAT THE SMOKE EVACUATION PENCIL HAD FLAME AT TIP AND MADE POPPING NOISES DURING SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH REPORT MW 5101090 THAT THE SMOKE EVACUATION PENCIL HAD FLAME AT TIP AND MADE POPPING NOISES DURING SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854464 PUSH-BUTTON SMOKE EVAC. PENCIL, COATED ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES GEI STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1