BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6761874 · Received August 2, 2017

    Report

    Report Number
    1045254-2017-00265
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 7, 2017
    Report Date
    July 7, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 1845000 ((B)(4)): INITIAL INSPECTION OF THE INDIGO DRILL/HANDPIECE INDICATES THAT THE ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULTS ARE AS FOLLOWS: 28.3 DEGREES C AT T1 AND 29.1 DEGREES C AT T2. THE SERVICE REPORT INDICATES THERE WAS NO MALFUNCTION OF THE DEVICE. THE INSIDE OF THE DISASSEMBLED DEVICE WAS CLEANED. THE MOTOR ASSEMBLY, COLLET, AND CABLE ASSEMBLY WERE REPLACED FOR PREVENTIVE MEASURES. THE DEVICE WAS TESTED TO SPECIFICATIONS. 1845010 ((B)(4)): INITIAL INSPECTION OF THE INDIGO STRAIGHT ATTACHMENT INDICATES THAT THE ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULT WAS 27.8 DEGREES C. THE SERVICE REPORT INDICATES THERE WAS NO MALFUNCTION. THE INSIDE OF THE DISASSEMBLED DEVICE WAS CLEANED. SOME PARTS, INCLUDING BEARINGS, WERE REPLACED FOR PREVENTIVE MEASURES. THE DEVICE WAS TESTED TO SPECIFICATIONS. THE 1845020 ((B)(4)): INITIAL INSPECTION OF THE INDIGO ANGLED ATTACHMENT INDICATES THAT A ONE-MINUTE PRE-REPAIR TEMPERATURE TEST COULD NOT BE PERFORMED. THE SERVICE REPORT INDICATES THE REPORTED MALFUNCTION COULD NOT BE REPLICATED. HOWEVER, DETERIORATION OF THE BEARINGS WERE NOTED. THE INSIDE OF THE DISASSEMBLED DEVICE WAS CLEANED. SOME PARTS, INCLUDING BEARINGS, WERE REPLACED FOR PREVENTIVE MEASURES. THE DEVICE WAS TESTED TO SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS. 1845010 (ATTACHMENT, INDIGO OTOL, STRAIGHT): SERIAL NUMBER -(B)(4); LOT NUMBER ¿ 209661904; MANUFACTURE DATE ¿ JUNE 29, 2015; (B)(4); 510K - K081475. 1845020 (ATTACHMENT, INDIGO OTOL, ANGLED); SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 210461789; MANUFACTURE DATE ¿ DECEMBER 5, 2015; (B)(4); 510K - K081475. THE INDIGO HANDPIECE, STRAIGHT ATTACHMENT, AND ANGLED ATTACHMENT HAVE NOT BEEN RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A TYMPANOPLASTY SURGERY THE INDIGO HANDPIECE/DRILL, ANGLED ATTACHMENT, AND STRAIGHT ATTACHMENT OVERHEATED. ALSO, THE ANGLED ATTACHMENT WAS CONNECTED TO THE HANDPIECE AND THE BUR COULD NOT BE CONNECTED. THERE WAS NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542237 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 209866386

    Patients

    Seq Age Sex Outcome Treatment
    1