BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6634972 · Received June 12, 2017

    Report

    Report Number
    1045254-2017-00184
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Date of Event
    May 15, 2017
    Report Date
    December 8, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): A 1845010: INDIGO OTOL STRAIGHT ATTACHMENT, SERIAL # (B)(4), LOT # 207255663, UDI # (B)(4), MANUFACTURE DATE IS JULY 30, 2013, 510(K) # K081475. A 1845020: INDIGO OTOL ANGLED ATTACHMENT, SERIAL # (B)(4), LOT # 208330701, UDI # (B)(4), MANUFACTURE DATE IS JULY 30, 2014, 510(K) # K081475. INDIGO HANDPIECE (PRODUCT # 1845000) WAS NOT RETURNED FOR ANALYSIS, EVALUATION WAS NOT PERFORMED ON THIS DEVICE. INDIGO STRAIGHT ATTACHMENT (PRODUCT # 1845010) WAS RETURNED FOR ANALYSIS. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. INDIGO ANGLED ATTACHMENT (PRODUCT # 1845020) WAS RETURNED FOR ANALYSIS. EVALUATION OF THE DEVICE COULD NOT CONFIRM THE DEVICE HEATING UP. TEMPERATURE TESTING COULD NOT BE PERFORMED SINCE THE STEM ON THE DEVICE WOULD NOT HOLD FOR TESTING. ANALYSIS FOUND THAT THE O-RINGS WERE WORN AND THE BEARINGS WERE CORRODED. THE DEVICE WAS REPAIRED, TESTED TO ALL MANUFACTURING PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. 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

    PRODUCT EVALUATION: CONCOMITANT DEVICE: 1845010: INDIGO OTOL STRAIGHT ATTACHMENT, SERIAL # (B)(4): THE DEVICE WAS EVALUATED BY SERVICE AND REPAIR; THERE WAS NOTHING STUCK IN THE ATTACHMENT, HOWEVER, THE BEARINGS WERE CORRODED. THE DEVICE WAS REPAIRED AND SUCCESSFULLY TESTED TO SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE HEATED UP GRADUALLY THROUGHOUT THE COURSE OF THE PROCEDURE. THE PROCEDURE WAS CONTINUED BY WRAPPING THE HANDPIECE IN A WET CLOTH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HANDPIECE AND ATTACHMENTS OVERHEATED. BUR WAS STUCK IN THE ATTACHMENTS. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414735 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 206259543 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1