BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® HANDPIECE - UNKNOWN

    MDR report key: 6804197 · Received August 18, 2017

    Report

    Report Number
    1045254-2017-00288
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    June 8, 2017
    Report Date
    June 12, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES: EF200RF (FOOT CONTROL IPC, REFURB): SERIAL NUMBER ¿ (B)(4); LOT NUMBER ¿ 206650463; MANUFACTURED DATE ¿ FEBRUARY 1, 2013; 510K - K081475; UDI NUMBER - (B)(4) EC300RF (CONSOLE IPC, REFURB): SERIAL NUMBER ¿ (B)(4); LOT NUMBER ¿ 207655266; MANUFACTURE DATE ¿ OCTOBER 28, 2013; 510K - K081475; UDI NUMBER - (B)(4) HANDPIECE (XOM UNKNOWN DRILL): THE CUSTOMER INDICATED THAT THE HANDPIECE IS STILL IN USE. IT HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. EF200RF (FOOT CONTROL, IPC REFURB): THE PRODUCT ANALYSIS INDICATES THE FOOT CONTROL DID NOT MAKE A HANDPIECE OVERHEAT. THE DEVICE CAME IN WITH A WORN RUBBER FOOT. THE FOOT WAS REPLACED. THE DEVICE WAS CLEANED, REPAIRED, AND TESTED TO MANUFACTURING SPECIFICATIONS. EC300RF (CONSOLE, IPC REFURB): THE PRODUCT ANALYSIS INDICATES THAT THE DEVICE WAS PLACED IN BURN-IN FOR 24 HOURS AND THE REPORTED ¿ERROR CODE¿ COULD NOT BE VERIFIED. THE DEVICE CAME IN WITH A CRACKED TOUCHSCREEN AND WORN GASKET. THE TOUCHSCREEN AND GASKET WERE REPLACED. THE DEVICE WAS CLEANED, REPAIRED, AND TESTED TO MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CONSOLE TOUCHSCREEN WAS NOT REGISTERING AND DISPLAYED ERROR WHEN PLUGGED IN THE FOOT SWITCH. WHEN ENGAGED, THE HANDPIECE HEATED UP. THE FOOT SWITCH WAS REPLACED AND THE HEAT ISSUE WAS RESOLVED. THERE WAS NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586005 XPS® HANDPIECE - UNKNOWN DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. XOM UNKNOWN DRILL

    Patients

    Seq Age Sex Outcome Treatment
    1