BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 5481192 · Received March 4, 2016

    Report

    Report Number
    1045254-2016-00066
    Event Type
    Malfunction
    Date Received
    March 4, 2016
    Report Date
    February 8, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): HIGH SPEED INDIGO OTOLOGIC DRILL (1845000); SN: (B)(4); MANUFACTURED: SEPTEMBER 10, 2013; 510K: K081475. HIGH SPEED INDIGO OTOLOGIC DRILL (1845000); SN: (B)(4); MANUFACTURED: INVALID SERIAL NUMBER; 510K: K081475. (B)(4) IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, NO DEVICES WERE RECEIVED FOR EVALUATION. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SERVICE REPORT: DRILL 1845000 INDIGO HIGH SPEED OTOLOGIC, SERIAL NUMBER (B)(4), LOT NUMBER 209653450 -COULD NOT VERIFY OVERHEATING BUT DRILL WAS RUNNING ROUGH. PERFORMED PRE-TEMPERATURE TEST. AMBIENT TEMPERATURE WAS 71.2 F AND IN 1 MIN OF TESTING DRILL TEMPERATURE WERE T1 - 78.3 F AND T2 - 77.6 F. DRILLS COLLET IS MAKE STRANGE NOISE AND RUNNING ROUGH. REPLACED COLLET. ITEM WAS REPAIRED CLEANED AND TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. DRILL 1845000 INDIGO HIGH SPEED OTOLOGIC, SERIAL NUMBER (B)(4), LOT NUMBER 207374899- COULD NOT VERIFY OVERHEATING BUT DRILL WAS RUNNING ROUGH. PERFORMED PRE-TEMPERATURE TEST. AMBIENT TEMPERATURE WAS 72.7F AND IN 1 MIN OF TESTING DRILL TEMPERATURES WERE T1 - 78.3 F AND T2 - 79.8 F. DRILL'S COLLET IS MAKING STRANGE NOISE AND RUNNING ROUGH. REPLACED COLLET. ITEM WAS REPAIRED CLEANED AND TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. DRILL 1845000 INDIGO HIGH SPD OTOL ROHS, SERIAL NUMBER (B)(4), LOT NUMBER 208370503- \ COULD NOT VERIFY OVERHEATING, BUT DRILL WAS RUNNING ROUGH. PERFORMED PRE-TEMPERATURE TEST. AMBIENT TEMPERATURE WAS 71.0 F AND IN 1 MIN OF TESTING DRILL TEMPERATURE WERE T1 - 78.8 F AND T2 - 76.5 F. DRILL'S COLLET IS MAKE STRANGE NOISE AND RUNNING ROUGH. REPLACED COLLET. ITEM WAS REPAIRED CLEANED AND TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE (3) HIGH SPEED INDIGO OTOLOGIC DRILLS GOT "HOT" DURING USE. THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136684 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 209653450

    Patients

    Seq Age Sex Outcome Treatment
    1