BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6994487 · Received November 1, 2017

    Report

    Report Number
    1045254-2017-00388
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 3, 2017
    Report Date
    June 21, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 1845000 (DRILL, INDIGO HIGH SPEED OTOLOGIC), SERIAL NUMBER (B)(4): THE DEVICE WAS RETURNED FOR ANALYSIS. ANALYSIS DID NOT CONFIRM THE REPORTED EVENT OF HANDPIECE HEATED UP. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED. THE FOLLOWING ARE THE TEMPERATURES OF THE DEVICE: AMBIENT TEMPERATURE WAS 78.1 DEGREES F AND MAX TEMPERATURE AFTER 1 MINUTE WAS 81.8 DEGREES F. NO FAULT FOUND WITH THE HANDPIECE. THE DEVICE WAS CLEANED AND TESTED TO THE MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE: PRODUCT ID 1845020 - ATTACHMENT INDIGO ANGLED, SERIAL # (B)(4), LOT # 210760334 MANUFACTURED DATE: APRIL 19, 2016, 510(K) # K081475, UDI (B)(4). PRODUCT ID 1845010 - ATTACHMENT INDIGO STRAIGHT, SERIAL # (B)(4) , LOT # 210812946 MANUFACTURED DATE: FEBRUARY 15, 2016, 510(K) # K081475, UDI (B)(4). NO PRODUCT ANALYSIS RESULTS AVAILABLE. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES RETURNED FOR ANALYSIS. PRODUCT NUMBER 1845020 ATTACHMENT INDIGO ANGLED, SERIAL NUMBER (B)(4): ANALYSIS DID NOT CONFIRM THE REPORTED EVENT OF HANDPIECE HEATED UP. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED - TEMPERATURE AFTER 5 MINUTES WAS 97.8 DEGREES F. THE DEVICE WAS CLEANED AND TESTED TO THE MANUFACTURING SPECIFICATIONS. PRODUCT NUMBER 1845010 ATTACHMENT INDIGO STRAIGHT, SERIAL NUMBER (B)(4): ANALYSIS DID NOT CONFIRM THE REPORTED EVENT OF HANDPIECE HEATED UP. PRE-REPAIR TEMPERATURE TESTING WAS PERFORMED - TEMPERATURE AFTER 5 MINUTES WAS 84.1 DEGREES F. THE DEVICE WAS CLEANED AND TESTED TO THE MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE HANDPIECE OVERHEATED IMMEDIATELY (LESS THAN ONE MINUTE) DURING SETUP AND TESTING PRIOR TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HANDPIECE WAS HEATING UP, BUR ROTATED SPORADICALLY. THERE WAS NO PATIENT/STAFF IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774079 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 211085906 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1