BEUDAMED
    FDA Adverse Event Other Summary report: N

    ART-E1 ELECTROSURGERY UNIT

    MDR report key: 1425438 · Received July 27, 2009

    Report

    Report Number
    9710363-2009-00001
    Event Type
    Other
    Date Received
    July 27, 2009
    Date of Event
    July 11, 2007
    Report Date
    July 20, 2009
    Manufacturer
    BONART CO. LTD.
    Product Code
    EKZ
    PMA / PMN Number
    K020080
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICES WITHIN THE SAME MANUFACTURING AND SHIPMENT BATCH DID NOT REVEAL ANY KINDS OF MALFUNCTIONS IN DESIGN NOR IN OPERATIONS. WE HAD DETERMINED THAT OUR DOCUMENTATION AND RECORD ON FILE DID NOT SHOW ANY MISLABELING. IT WAS A SIMPLE MIXED UP BY OUR ASSEMBLY PERSONNEL (HUMAN ERROR) DURING THE PACKAGING PROCESS. FOLLOWING ACTIONS HAVE BEEN IN PROCESS: THOROUGH REVIEW OF OUR PRODUCTION AND PACKAGING PROCEDURES. CONTINUOUS PERSONNEL TRAINING. RECOMMENDED UNITED STATES INITIAL DISTRIBUTOR AND IMPORTER, (B) (4). FDA (B) (4) TO FORWARD IMMEDIATE PRODUCT ALERT NOTIFICATION TO THEIR CUSTOMERS ABOUT REPLACEMENT TO BE SENT OUT TO ANY POSSIBLE INCORRECT TYPE OF HAND PIECES THAT HAD COME WITH THIS BATCH OF SHIPMENT.

    Description of Event or Problem · 1

    ON 04/2009, WE WERE INFORMED BY OUR UNITED STATES INITIAL DISTRIBUTOR AND IMPORTER, (B) (4) THAT THEY HAD RECEIVED A LETTER FROM THE PATIENT'S LAWYER DATED 04/11/2009 STATING THAT THEY HAD BEEN IN INCIDENT BACK ON (B) (6) 2007 WHERE PATIENT WAS BURNED DURING A PROCEDURE BY THE DENTIST AT THIS DENTAL CLINIC WHILE USING THE HAND PIECE WITH BLADE OPTION THAT WAS BEING CLAIMED TO HAVE BEEN INCLUDED WITH THE BONART'S ART-E1 ELECTROSURGERY UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ART-E1 ELECTROSURGERY UNIT DENTAL ELECTROSURGICAL UNIT & ACCESS. EKZ BONART CO. LTD. ART-EI 12/13/2006

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other