BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 5128240 · Received October 5, 2015

    Report

    Report Number
    1045254-2015-00321
    Event Type
    Injury
    Date Received
    October 5, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 10, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION: -- INDIGO HIGH SPEED DRILL 1845000: IN SERVICE AND REPAIR THE REASON FOR RETURN HAS BEEN REPRODUCED; THE INCONTROLLABLE MOVEMENT COMES FROM THE INDIGO HANDPIECE. THE INDIGO HANDPIECE WAS DISASSEMBLED FOR FURTHER INSPECTION. THE COLLET SHAFT IS WORN INTERNALLY; THE BURR WOBBLES IN THE SHAFT. THE COLLET HAS BEEN REPLACED. THE INDIGO HANDPIECE HAS BEEN SUCCESSFULLY TESTED ACCORDING TO SPECIFICATIONS. - INDIGO ANGLED ATTACHMENT 1845020: IN SERVICE AND REPAIR THE ANGLED ATTACHMENT WAS OPENED FOR FURTHER INSPECTION. THE LASER MARKINGS ARE FADED AND THE OUTPUT DRIVE SHAFT IS PITTING. THE MANDATORY PARTS HAVE BEEN REPLACED, THE OUTPUT DRIVE SHAFT HAS BEEN REPLACED, THE LASER MARKINGS HAVE BEEN REDONE AND ALL PARTS HAVE BEEN CLEANED. THE INDIGO STRAIGHT ATTACHMENT HAS BEEN SUCCESSFULLY TESTED ACCORDING TO SPECIFICATIONS. -- INDIGO STRAIGHT ATTACHMENT 1845010: IN SERVICE AND REPAIR THE STRAIGHT ATTACHMENT WAS OPENED FOR FURTHER INSPECTION. THERE WAS NO FAULT FOUND WITH THE DEVICE. THE BEARINGS AND RETAINING RING WERE REPLACED AS PART OF PREVENTIVE MAINTENANCE. THE INDIGO STRAIGHT ATTACHMENT HAS BEEN SUCCESSFULLY TESTED ACCORDING TO SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES:1845020: ATTACHMENT 1845020 INDIGO OTOL ANGLED, S/N (B)(4), LOT 206105008 MANUFACTURED: 08/23/2012 -- 1845010: ATTACHMENT 1845010 INDIGO OTOL STRAIGHT, S/N (B)(4), LOT 208123252 MANUFACTURED: 03/17/2014 -- UNKNOWN PRODUCT NUMBER: BUR/BLADE. (B)(4). PRODUCT EVALUATION: DEVICES (DRILL AND ATTACHMENTS) ARE IN PROCESS OF BEING FORWARDED FOR ANALYSIS; EVALUATION EXPECTED BUT NOT YET BEGUN. IT WAS CONFIRMED THAT THE BUR/BLADE WAS DISCARDED BY THE USER FACILITY.

    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 CHOLESTEATOMA PROCEDURE, "THE INDIGO WAS BLOCKED SUDDENLY DURING THE DRILLING OF THE MASTOID BONE. STOP OF THE ROTATION OF THE DRILL CREATED AN INCONTROLLABLE MOVEMENT OF THE INDIGO WHICH HIT THE MASTOID AND FRACTURED IT CAUSING A MENINGEAL EXPOSURE (1CM). NO FLOW OF CEREBROSPINAL FLUID." IT WAS CONFIRMED THAT "BLOCKED SUDDENLY" MEANS THAT THE DRILL STOPPED WORKING, AND THAT THERE WAS NO CSF LEAK CAUSED BY THE FRACTURE; THE MENINGES WERE EXPOSED BUT REMAINED INTACT. THEY ARE UNSURE OF WHICH DEVICE COMPONENT ACTUALLY CAUSED THE BREACH. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658673 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 208183025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other