BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNACLAVE STERILIZER

    MDR report key: 1171352 · Received September 22, 2008

    Report

    Report Number
    1017522-2008-00001
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    PELTON & CRANE
    Product Code
    FLE
    PMA / PMN Number
    PRE-1976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HANDLE. THE PLASTIC HANDLE WAS RETURNED TO PELTON & CRANE FOR EVALUATION. THE FAILURE INVESTIGATION OF THE PART SHOWED, THE PLASTIC HANDLE MATERIAL WAS UNIFORM WITHOUT ANY SIGNS OF POROSITY OR FATIGUE. WE HAVE NO OTHER COMPLAINTS ON FILE THAT STATE AN EVENT LIKE THIS HAS EVER OCCURRED. THE CAUSE OF THE DOOR TO OPEN WAS AN ELECTRICAL SOLENOID THAT WOULDN'T ENERGIZE WHICH UNLOCKS THE DOOR MECHANISM TO ALLOW THE OPERATOR TO OPEN THE DOOR WITH THE HANDLE LEVER BAR. THE OPERATORS INSTRUCTIONS STATE THAT THE SOLENOID PIN MUST BE PUSHED IN, IN ORDER TO ACTIVATE THE SOLENOID, IN ORDER TO OPEN THE DOOR WHICH THE OPERATOR WAS NOT DOING AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    A DENTAL ASSISTANT WAS USING A PELTON & CRANE MAGNACLAVE STERILIZER AND HAD JUST COMPLETED A STERILIZATION CYCLE. THE DENTAL ASSISTANT TRIED TO OPEN THE CHAMBER DOOR, BUT IT WOULD NOT OPEN. THE OPERATOR THEN PLACED BOTH HANDS ON THE HANDLE LEVER BAR AND PULLED DOWN FORCEFULLY TRYING TO OPEN THE DOOR WHEN SUDDENLY, THE DOOR HANDLE PLASTIC END COVER BROKE CAUSING LACERATIONS TO THE DENTAL ASSISTANT'S HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNACLAVE STERILIZER AUTOCLAVE FLE PELTON & CRANE A6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention