BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6429368 · Received March 23, 2017

    Report

    Report Number
    1045254-2017-00093
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    February 27, 2017
    Report Date
    February 27, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: -- INDIGO HANDPIECE 1845000 ¿ PRE-REPAIR TEMPERATURES RECORDED AFTER RUNNING THE DEVICE FOR 1 MINUTE AT 60,000 RPM: T1 ¿ 29.6 C, T2 ¿ 26.9 C. BEARINGS WERE REPLACED ON THE DEVICE DUE TO CORROSION. THE DEVICE WAS CLEANED, REPAIRED AND SUCCESSFULLY TESTED TO SPECIFICATIONS. -- STRAIGHT ATTACHMENT 1845010 ¿ PRE-REPAIR TEMPERATURE RECORDED AFTER RUNNING THE DEVICE FOR 1 MINUTE AT 60,000 RPM: 26.3 C. -- ANGLED ATTACHMENT 1845020 ¿ PRE-REPAIR TEMPERATURE RECORDED AFTER RUNNING THE DEVICE FOR 1 MINUTE AT 60,000 RPM: 27.3 C. 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

    CONCOMITANT DEVICES: 1845010: ATTACHMENT 1845010 INDIGO OTOL STRAIGHT, S/N (B)(4), LOT 206363140, UDI # (B)(4), MANUFACTURED: 2012/11/20 - 1845020: ATTACHMENT 1845020 INDIGO OTOL ANGLED, S/N (B)(4), LOT 206374943, UDI # (B)(4), MANUFACTURED: 2012/11/27. PRODUCT EVALUATION: ANALYSIS RESULTS ARE NOT AVAILABLE; THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MASTOIDECTOMY, THE PRODUCT OVERHEATED IMMEDIATELY AND IT WAS TOO HOT TO BE HELD BY THE PHYSICIAN." IT WAS CONFIRMED THAT THE DRILL OVERHEATING WHEN USING EACH OF THE ATTACHMENTS. A BACKUP DRILL SYSTEM WAS USED TO COMPLETE THE PROCEDURE; THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211224 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 206566959

    Patients

    Seq Age Sex Outcome Treatment
    1