BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 7327820 · Received March 9, 2018

    Report

    Report Number
    1045254-2018-00100
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 5, 2018
    Report Date
    April 30, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT PERFORMED; THE DEVICE WAS NOT RETURNED FOR ANALYSIS. CONCOMITANT DEVICES: PRODUCT: ATTACHMENT 1845020 INDIGO OTOL ANGLED, SERIAL NUMBER: (B)(4), LOT NUMBER: 213340978, MANUFACTURE DATE: MAY 18, 2017, 510(K) NUMBER: K081475, UDI: (B)(4), PRODUCT: ATTACHMENT 1845010 INDIGO OTOL STRAIGHT, SERIAL NUMBER: (B)(4), LOT NUMBER: 213035872, MANUFACTURE DATE: MARCH 29, 2017, 510(K) NUMBER: K081475, UDI: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE WAS PERFORMED AND COULD NOT CONFIRM THE REPORTED ISSUE OF "GETS VERY HOT". THE PRE-REPAIR TEMPERATURE TESTS FOUND THE DEVICE ROSE FROM 74 DEGREES FAHRENHEIT TO 82 DEGREES FAHRENHEIT. THE EVALUATION NOTES THE MOTOR SOUNDS ROUGH WHILE IN USE AND THE MOTOR BEARINGS ARE WORN. CONCOMITANT DEVICES: PRODUCT: ATTACHMENT 1845020 INDIGO OTOL ANGLED, SERIAL NUMBER: (B)(4), LOT NUMBER: 213340978, MANUFACTURE DATE: MAY 18, 2017, 510(K) NUMBER: K081475, UDI: (B)(4). THE EVALUATION OF THE DEVICE WAS PERFORMED AND COULD NOT CONFIRM THE REPORTED ISSUE OF "GETS VERY HOT". THE PRE-REPAIR TEMPERATURE TESTS AFTER 5 MINUTES NOTED THE FOLLOWING READINGS; T1: 92 DEGREES FAHRENHEIT, T2: 89 DEGREES FAHRENHEIT, AND T3: 88 DEGREES FAHRENHEIT. THE EVALUATION NOTES THE DEVICE SOUNDS ROUGH WHILE IN USE AND THE INTERNAL BEARINGS ARE WORN. PRODUCT: 1845010 INDIGO OTOL STRAIGHT, SERIAL NUMBER: (B)(4), LOT NUMBER: 213035872, MANUFACTURE DATE: MARCH 29, 2017, 510(K) NUMBER: K081475, UDI: (B)(4). THE EVALUATION OF THE DEVICE WAS PERFORMED AND COULD NOT CONFIRM THE REPORTED ISSUE OF "GETS VERY HOT". THE PRE-REPAIR TEMPERATURE TESTS FOUND THE DEVICE ROSE FROM 80 DEGREES FAHRENHEIT TO 87 DEGREES FAHRENHEIT. THE EVALUATION NOTES THE DEVICE SOUNDS ROUGH WHILE IN USE AND THE BEARINGS ARE WORN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INDIGO SYSTEM GETS VERY HOT DURING USE. THE CUSTOMER REPORTED THAT NO PATIENT WAS INVOLVED AND THAT ONLY THE SURGEON WAS INVOLVED IN THE EVENT. THERE WERE NO INJURIES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170003 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 213368226 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1