BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6926430 · Received October 7, 2017

    Report

    Report Number
    1045254-2017-00348
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    September 11, 2017
    Report Date
    November 28, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): A 1845020 (ATTACHMENT, INDIGO OTOL ANGLED): SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 210461789; MANUFACTURED DATE ¿ DECEMBER 5, 2015; UDI # - (B)(4); 510K - K081475. INITIAL REPORTER'S PHONE NUMBER WITH EXTENSION: (B)(6). A 1845000 (DRILL, INDIGO HIGH SPEED OTOLOGIC): THE DEVICE HAS BEEN RETURNED. THE PRODUCT ANALYSIS RESULTS ARE PENDING COMPLETION OF THE EVALUATION. 1845020 (ATTACHMENT, INDIGO OTOL ANGLED): THE DEVICE HAS NOT BEEN RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A 1845000, INDIGO DRILL (SERIAL NUMBER (B)(4)): THERE WAS NO OVERHEATING FOUND. THE DRILL WAS RUN FOR 5 MINUTES AT 52,000 RPM AND THE TEMPERATURE WAS 88 DEGREES F. 1845020, INDIGO ANGLED ATTACHMENT (SERIAL NUMBER (B)(4)): THERE WAS NO FAILURE FOUND. THE ANGLED ATTACHMENT WAS RUN FOR 5 MINUTES AT 52,000 RPM AND THE TEMPERATURE WAS 90 DEGREES F. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ANGLED DRILL HEATED UP WITHIN SECONDS. A REPLACEMENT DRILL WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705679 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 210276789 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1