BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOOTSWITCH 1895420 XPS MULTIFUNCTIONAL

    MDR report key: 1359440 · Received April 9, 2009

    Report

    Report Number
    1045254-2009-00010
    Event Type
    Injury
    Date Received
    April 9, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 10, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K041523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AND UPON OPENING THE BOX, PHOTOGRAPHS AND VIDEO WERE TAKEN IN THE "AS RECEIVED CONDITION". VISUAL INSPECTION SHOWED THE FOOTSWITCH PEDAL WAS IN A DEPRESSED CONDITION AND OF THE TWO SPRINGS REQUIRED, ONE WAS MISSING AND THE OTHER WAS DEFORMED AND NOT SEATED PROPERLY. THIS RESULTED IN THE PEDAL NOT RETURNING TO THE UPMOST POSITION. THE PRODUCT HAS BEEN REVIEWED BY SERVICE AND REPAIR, QUALITY ENGINEER, AND CUSTOMER LOYALTY. FUNCTIONAL TESTS SHOWED THE HANDPIECE WOULD CONTINUE RUNNING IF THE SPRINGS WERE BINDING OR MISSING. AFTER REMOVING THE TOP PART OF THE ROOT PEDAL VISUAL INSPECTION SHOWED DAMAGE TO THE MAGNETIC PEDAL ACTUATOR IN THE FORM OF LINEAR INDENTATIONS IN THE SIZE AND SHAPE OF THE SPRING INDICATING EXCESSIVE FORCE BEING USED ON THE FOOT PEDAL DURING OPERATION. A REVIEW OF THE USER GUIDE STATES "ALWAYS INSPECT THE COMPONENTS BEFORE AND AFTER USE FOR ANY DAMAGE. IF DAMAGE IS OBSERVED, DO NOT USE DAMAGED PART UNTIL IT IS REPLACED.", AND "INSPECT COMPONENTS FOR DAMAGE AND DETERMINE IF SYSTEM IS READY TO USE." A REVIEW OF THE HARDCOPY MANUFACTURING DOCUMENT SHOWED NO ANOMALIES. ADDITIONAL PATIENT INFORMATION WAS REQUESTED AND THE CUSTOMER STATED "THE PATIENT HAD RECOVERED FULLY THE DAY AFTER THE OPERATION AND HAD NOT NEEDED ANY ABNORMAL FOLLOW UP, APART FROM THE USUAL POST OP THAT THE DOCTOR CONDUCTS."

    Description of Event or Problem · 1

    THE XPS FOOTPEDAL IS STICKING AND NOT SPRINGING BACK CAUSING THE MICRODEBRIDER TO KEEP ROTATING CAUSING INJURY TO PATIENT. INJURY COMMENTS STATED "MICRODEBRIDER KEPT ON ROTATING CAUSING A HOLE THROUGH SEPTUM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTSWITCH 1895420 XPS MULTIFUNCTIONAL NA ERL MEDTRONIC XOMED, INC. 1895420 39154400

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other