BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC H-II

    MDR report key: 829472 · Received March 1, 2007

    Report

    Report Number
    2025576-2007-00002
    Event Type
    Malfunction
    Date Received
    March 1, 2007
    Date of Event
    January 11, 2007
    Report Date
    February 1, 2007
    Manufacturer
    BYRON MEDICAL
    Product Code
    EKX
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR ARC H-II RECIPROCATING HANDPIECES WERE RECEIVED. THE FIRST TWO FROM LOT 264-06 WERE RECEIVED UNUSED AND STILL IN THE STERILE PACKAGE. THE PACKAGES WERE OPENED AND THE HANDLES WERE TESTED. NO DEFECTS WERE FOUND. THE CANNULA WORKED IMMEDIATELY UPON START UP. WE RECEIVED ONE HANDLE FROM LOT 181-06 IN AN OPEN STERILE BAG. THE HANDLE SWITCH WAS IN THE OFF POSITION WHEN RECEIVED. THE HANDLE STARTED IMMEDIATELY UPON START-UP. THE HANDLE WAS TESTED FOR FIVE MINUTES TURNING ON AND OFF AND CHANGING SPEED. NO FAILURES WERE FOUND. ONE ADD'L HANDLE WAS RECEIVED FROM AN UNK LOT. THIS HANDLE DID NOT WORK WHEN THE SWITCH WAS TURNED ON. THIS FAILURE WAS DETERMINED TO BE CAUSED BY A DISCONNECTED RIVET THAT CONNECTS THE POSITIVE CONNECTOR OF THE BATTERY TERMINAL TO THE CIRCUIT BOARD. REVIEW OF PREVIOUS COMPLAINT AND RETURN RECORDS INDICATES THAT THIS IS THE FIRST TIME THIS EVENT HAS OCCURRED.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED TO BYRON MEDICAL ON USER REPORT. THE REPORT WAS RECEIVED ON 2/1/07. REPORTED ON MDR FROM CUSTOMER. EVENT DESC: RECIPROCATING HANDPIECE WOULD NOT RECIPROCATE. STAFF USED ANOTHER HANDPIECE. ALSO RECEIVED A SECOND HANDPIECE FROM ANOTHER CASE WITH THE SAME COMPLAINT. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). FOLLOW-UP INFO RECEIVED FROM CUSTOMER. PER THE BIOMEDICAL ENGINEER, THERE WERE NO PT INJURIES OR POTENTIAL FOR PT INJURIES AS A RESULT OF THESE EVENTS. OTHER ARC H-II HANDLES WERE USED TO PERFORM THE SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARC H-II DISPOSABLE RECIPROCATING HANDPIECE EKX BYRON MEDICAL ARC H-II 181-06

    Patients

    Seq Age Sex Outcome Treatment
    1 *