BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE

    MDR report key: 12009162 · Received June 16, 2021

    Report

    Report Number
    3007208013-2021-00019
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Report Date
    July 15, 2021
    Product Code
    HOG
    UDI-DI
    10607151000100
    PMA / PMN Number
    K950520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE RETURNED DEVICE, IT WAS TESTED WITH THE RETURNED BATTERIES AND TWO OTHER BATTERIES THAT WERE FOUND ON SITE. THE DEVICE FUNCTIONED AS INTENDED AND PER PRODUCT SPECIFICATIONS USING ALL BATTERIES. - AS A RESULT THE COMPLAINT COULD NOT BE CONFIRMED. THE TRUE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE EVALUATION. THE COMPLAINT RATE FOR THIS ISSUE IS LOW AND NO FURTHER ACTIONS ARE REQUIRED. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    WE ARE STILL ANTICIPATING THE RETURN OF THE DEVICE. AT THIS TIME THE LOT NUMBER AND DATE OF PURCHASE IS UNKNOWN. THERE HAS BEEN A TOTAL OF (B)(4) SOLD OF THIS DEVICE SINCE 2016 WITH 2 ADDITIONAL COMPLAINTS RECORDED FOR SIMILAR OCCURRENCES. (0.19%). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN EVALUATED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE DOCTOR ATTEMPTED TO USE THE DEVICE ON A PATIENT, BUT IT STOPPED WORKING SECONDS AFTER THE BUTTON WAS PUSHED. THERE WAS NO DELAY IN TREATMENT AND THERE WAS NO HARM TO THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910675 BOVIE OPTHALMIC BURR HOG 0010 2020-06-22 10607151000100

    Patients

    Seq Age Sex Outcome Treatment
    1