BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON ROHS ANSPACH CONSOLE - 200030

    MDR report key: 9997257 · Received April 24, 2020

    Report

    Report Number
    3010266064-2020-00973
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    March 29, 2019
    Report Date
    April 24, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT. THUS, VISUAL INSPECTION COULD NOT BE PERFORMED. THERE WAS NO PART/SERIAL/LOT NUMBER PROVIDED FOR DHR REVIEW SO IT COULD NOT BE CONCLUDED IF THE DEVICE MET THE MANUFACTURING SPECIFICATIONS. A COMPLAINT HISTORY REVIEW IDENTIFIED SIMILAR EVENTS. FUNCTIONAL INSPECTION WAS PERFORMED BY THE SERVICE TEAM WHEN THE SYSTEM WAS RETURNED TO OKC FOR SERVICE. IT WAS FOUND THAT WHEN THE SYSTEM WAS SERVICED, THERE WAS NO EVIDENCE OF THE E2 ERROR. IT WAS REPORTED ON THE FIELD REPORT THAT THE ONLY WAY OF CLEARING THE ERROR WAS BY REBOOTING THE SYSTEM AND THE DRILL USED WITH THE SYSTEM WAS NOT SWAPPED. THIS IS INDICATIVE OF A FALSE ANSPACH E2 ERROR, WHEN THE E2 ERROR (WHICH TYPICALLY INDICATES A JAM) PRESENTS ITSELF WITHOUT A JAM AND CAN ONLY BE RESOLVED WITH A SYSTEM REBOOT. WE WERE ABLE TO CONFIRM THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. THE MALFUNCTION IS LIKELY DUE TO A SUPPLIER/RAW MATERIAL FAULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEMO, AN E2 ERROR OCCURRED REQUIRING  SYSTEM REBOOT. IT OCCURRED IMMEDIATELY WHEN THE FOOTPEDAL WAS PRESSED THE FIRST TIME ENTERED CUTTING. THE DRILL COULD SPIN FREELY BY HAND, DRILL WAS DISASSEMBLED AND REASSEMBLED. UNPLUGGED AND PLUGGED THE DRILL BACK IN. NO BACKUP DRILL AVAILABLE. SWITCHED TO MANUAL MODE. SYSTEM REBOOTED AND THE ERROR DID NOT APPEAR. PER INVESTIGATION, THE E2 WAS CAUSED BY THE CONSOLE AND NOT THE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458888 NON ROHS ANSPACH CONSOLE - 200030 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1