BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 6529606 · Received April 28, 2017

    Report

    Report Number
    1045254-2017-00127
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    March 29, 2017
    Report Date
    March 30, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933690
    PMA / PMN Number
    K081475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1845000, DRILL 1845000, INDIGO HIGH SPEED. PRODUCT EVALUATION: ANALYSIS RESULTS ARE NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: 1845000: DRILL 1845000 INDIGO HIGH SPEED OTOLOGIC, S/N (B)(4), LOT 209294385 MANUFACTURED DATE: 2015-03-05 UDI: (B)(4). PRODUCT EVALUATION: -- 1845020: ATTACHMENT INDIGO OTOL ANGLED: THE DEVICE WAS RECEIVED IN THE HALF LOCK/UNLOCK POSITION. IT WAS NOT POSSIBLE TO PERFORM PRE-REPAIR TEMPERATURE TESTS; NO BUR COULD BE INSERTED. THE DEVICE WAS FOUND TO BE INTERNALLY POLLUTED AND CORRODED AND THE BUR LOCK BEARINGS WERE STUCK IN THE SHAFT. THE DEVICE CLEANED, PARTS REPLACED, REPAIRED AND SUCCESSFULLY TESTED TO SPECIFICATIONS. -- 1845000: DRILL INDIGO HIGH SPEED OTOLOGIC: THE DEVICE WAS RECEIVED IN GOOD COSMETIC CONDITION. PRE-REPAIR TEMPERATURE TEST RESULTS WERE PERFORMED. AMBIENT TEMPERATURE WAS 77 F, AND AFTER RUNNING THE DEVICE FOR 1 MINUTE THE TEMPERATURE WAS 81 F. THERE WAS NO FAULT FOUND WITH THE DEVICE; IT WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT WHILE USING THE HANDPIECE THEY HEARD A "CLICK" AND THEN THE ATTACHMENT "EXPLODED"; IT GOT VERY HOT. THE SURGEON¿S HANDS MAY HAVE BEEN BURNT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT; HOWEVER, AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: IT WAS CONFIRMED THAT THE PHYSICIAN SUSTAINED "GRADE 1 BURN: SUPERFICIAL LAYER IRRITATION: RED WITHOUT BLISTER", WHICH WAS RUN UNDER COLD WATER FOR RELIEF. CLARIFICATION OF THE EVENT: "THE SURGEON WAS DRILLING IN THE BONE. THE DRILL DID GO WELL. BUT SUDDENLY THERE WAS A STRANGE NOISE AND THERE WAS A FORCE ON THE DRILL. AFTER THAT IT BECAME OVERHEATED. ACCIDENT HAPPENED AFTER 20 MINUTES OF DRILLING WITHOUT ANY PROBLEM." IT WAS ALSO CONFIRMED THAT IRRIGATION WAS PRIMED AND RUNNING AT THE TIME OF THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312015 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845020 209341498 00613994933690

    Patients

    Seq Age Sex Outcome Treatment
    1 Other