BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERMAX ELITE SHAVER HANDPIECE

    MDR report key: 3515752 · Received December 11, 2013

    Report

    Report Number
    1643264-2013-00023
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    November 12, 2013
    Report Date
    November 12, 2013
    Manufacturer
    OKLAHOMA CITY MANUFACTURING SITE
    Product Code
    HAB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: PRODUCT FAILED FOR MOTOR SENSOR FAULT DURING FUNCTIONAL TESTING. A SENSOR FAULT OCCURRED WHILE ATTEMPTING TO RUN THE UNIT. UNABLE TO CONFIRM THAT UNIT HEATS UP. HALL BOARD IS DEFECTIVE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW OF THE DEVICE REVEALED THE FOLLOWING INFORMATION: THE THREE MAJOR COMPONENTS THAT MAKE UP THE POWERMAX ELITE HAND PIECE WERE RE-EXAMINED BY QUALITY ON FEBRUARY 4, 2014. THE HALL BOARD AND MOTOR SUBASSEMBLIES WERE FOUND TO BE FUNCTIONING PROPERLY; HOWEVER THE CABLE ASSEMBLY WAS FOUND TO HAVE AN INTERNAL SHORT CIRCUIT THAT IS CAUSING THE MOTOR TO MALFUNCTION. THE CABLE ASSEMBLY HAS VISIBLE DAMAGE AT THE MOTOR STRAIN RELIEF THAT MAY INDICATE THE LOCATION OF THE SHORT CIRCUIT. THIS IS ALSO THE MOST LIKELY AREA FOR THE CABLE TO FAIL AS IT IS AT THE WORKING END OF THE MOTOR. THIS UNIT HAS BEEN IN THE FIELD SINCE OCTOBER 19, 2012 AND APPEARS TO HAVE BEEN USED REPEATEDLY. THE FAILURE OF THE CABLE ASSEMBLY IS NOT CONSIDERED TO BE A MANUFACTURING DEFECT IN MATERIALS OR WORKMANSHIP AND MOST LIKELY THE RESULT OF WEAR AND TEAR OVER TIME. (B)(4).

    Description of Event or Problem · 1

    PRIOR TO STARTING A PROCEDURE UTILIZING THE POWERMAX ELITE SHAVER HANDPIECE, IT WAS REPORTED THAT THE HAND PIECE WAS OPENED, PLUGGED INTO THE CONSOLE, BLADE INSERTED AND THE SCRUB NURSE DETERMINED THE DEVICE TO NOT BE WORKING. THE CIRCULATING NURSE WENT AND GOT NEW HAND PIECE WHICH WAS OPENED AND PASSED INTO STERILE FIELD. THE ORIGINAL HAND PIECE WAS PASSED OUT OF STERILE FIELD TO THE CIRCULATING NURSE. AS SHE RECEIVED IT, THE HEATED HAND PIECE BURNED THE WEBBING BETWEEN HAS FOREFINGER AND THUMB CAUSING HER TO DROP IT. SHE RAN IT UNDER COLD WATER AND BANDAGED THE AREA. THE BURNED AREA HAD A SMALL BLISTER AND WAS COVERED WITH PLASTER. THE REPLACEMENT HAND PIECE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. FOLLOW UP WITH THE NURSE REPORTS THAT SHE IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646974 POWERMAX ELITE SHAVER HANDPIECE MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL HAB OKLAHOMA CITY MANUFACTURING SITE 72200616 AAL47795

    Patients

    Seq Age Sex Outcome Treatment
    1