BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYF HND SWTCH PENCL AUTOCLAVAB

    MDR report key: 7378713 · Received March 28, 2018

    Report

    Report Number
    1320894-2018-00078
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 1, 2018
    Report Date
    March 28, 2018
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K001159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT DURING A MOHS SURGERY ON (B)(6) 2018 THE HYFRECATOR HANDPIECE TIP FELL ONTO THE PATIENT DURING USE. THE SURGEON HAS REPORTED THAT THE PATIENT WAS NOT BURNED, NOR WAS ANY MEDICAL INTERVENTION REQUIRED. THERE WAS NO DELAY TO THE SURGERY REPORTED. THE SURGEON STATED THAT THE PROCEDURE WAS COMPLETED AS NORMAL USING THE SAME DEVICE. ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE; HOWEVER, NO RESPONSE WAS RECEIVED. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221602 HYF HND SWTCH PENCL AUTOCLAVAB HYFRECATOR ACCESSORIES GEI CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1