BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EOS SYSTEM

    MDR report key: 6567273 · Received May 15, 2017

    Report

    Report Number
    3006165260-2017-00001
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    April 14, 2017
    Report Date
    June 26, 2017
    Manufacturer
    EOS IMAGING
    Product Code
    KPR
    PMA / PMN Number
    K152788
    Removal / Correction Number
    REG-2017-0010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION OF PRODUCT ANALYSIS: THE HANDLES USED BY THE SITE SHOWED OBVIOUS SIGNS OF WEAR, NO LONGER ALLOWING SAFE USE OF THESE ACCESSORIES ON THE EOS SYSTEM. ADDITIONALLY, THE HANDLES WERE NOT USED PER LABELED INTENDED USE (LEAFLET D14.595.12.06)STATING: "ONLY FOR STABILIZING THE HAND OR ARM AND FOR FIXING THE HAND BY PRESSING THE STABILIZATION GRIP ON ANY SMOOTH, GASTIGHT SURFACE: SUCH AS WASH-BASIN, ON THE TABLE OF THE WHEELCHAIR, DESKS, ATTENTION: DON'T USE THE GRIP AS AN AID FOR STANDING UP OR AS A HOLDING GRIP!" LABELED INSTRUCTIONS ARE VERY CLEAR ON INTENDED USE AND MONITORING AND MAINTENANCE MEASURES TO BE TAKEN SUCH AS THE SAFETY INDICATOR. HOWEVER THESE INSTRUCTIONS WERE PROVIDED IN ENGLISH AND GERMAN ONLY TO THE FRENCH CUSTOMER, WHICH DIDN'T PROBABLY ALLOW HIM TO FULLY UNDERSTAND THE INTENDED USE OF THE HANDLES, MONITORING AND MAINTENANCE MEASURES. ON JUNE 1, 2017, EOS IMAGING HAS INITIATED A MEDICAL DEVICE REMOVAL OF THE ROTH MOBELI GRAB HANDLES USED WITH EOS SYSTEM: THE STABI VARIO MODEL INVOLVED IN THE INCIDENT BUT ALSO THE DUAL GRIP MODEL (MODEL # 14002 25 S) DISTRIBUTED BY EOS IMAGING AND THAT USES THE SAME OPERATING PRINCIPLE AS THE STABI VARIO HANDLE. THIS FIELD SAFETY CORRECTIVE ACTION BEARS INTERNAL REFERENCE REG-(B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION OF PRODUCT ANALYSIS: THE HANDLES USED BY THE SITE SHOWED OBVIOUS SIGNS OF WEAR, NO LONGER ALLOWING SAFE USE OF THESE ACCESSORIES ON THE EOS SYSTEM. ADDITIONALLY, THE HANDLES WERE NOT USED PER LABELED INTENDED USE (LEAFLET D14.595.12.06)STATING: "ONLY FOR STABILIZING THE HAND OR ARM AND FOR FIXING THE HAND BY PRESSING THE STABILIZATION GRIP ON ANY SMOOTH, GASTIGHT SURFACE: SUCH AS WASH-BASIN, ON THE TABLE OF THE WHEELCHAIR, DESKS, ATTENTION: DON'T USE THE GRIP AS AN AID FOR STANDING UP OR AS A HOLDING GRIP!" LABELED INSTRUCTIONS ARE VERY CLEAR ON INTENDED USE AND MONITORING AND MAINTENANCE MEASURES TO BE TAKEN SUCH AS THE SAFETY INDICATOR. HOWEVER THESE INSTRUCTIONS WERE PROVIDED IN ENGLISH AND GERMAN ONLY TO THE FRENCH CUSTOMER, WHICH DIDN'T PROBABLY ALLOW HIM TO FULLY UNDERSTAND THE INTENDED USE OF THE HANDLES, MONITORING AND MAINTENANCE MEASURES. ON JUNE 1, 2017, EOS IMAGING HAS INITIATED A MEDICAL DEVICE REMOVAL OF THE ROTH MOBELI GRAB HANDLES USED WITH EOS SYSTEM: THE STABI VARIO MODEL INVOLVED IN THE INCIDENT BUT ALSO THE DUAL GRIP MODEL (MODEL # 14002 25 S) DISTRIBUTED BY EOS IMAGING AND THAT USES THE SAME OPERATING PRINCIPLE AS THE STABI VARIO HANDLE. THIS FIELD SAFETY CORRECTIVE ACTION BEARS INTERNAL REFERENCE REG-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347873 EOS SYSTEM EOS SYSTEM KPR EOS IMAGING EOS SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other