BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAPOD EVO RT SYSTEM

    MDR report key: 3700636 · Received March 26, 2014

    Report

    Report Number
    9710332-2014-00002
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 27, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Product Code
    JAI
    PMA / PMN Number
    K072898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS CONCLUDED ITS INVESTIGATION. IT MUST BE ASSUMED THAT FOR THIS CASE THE SERVICE ENGINEER PERFORMING THE INSTALLATION ON SITE DID NOT APPLY THE TORQUE AS SPECIFIED IN THE SERVICE MANUAL (20 NM) WHEN MOUNTING THE HEXAPOD. THIS MAY HAVE BEEN CAUSED DUE TO THE APPARENTLY VERY SMALL INSERTION-DEPTH OF THE THREAD OF THE SCREW WHICH MAY HAVE BEEN JUSTIFIED AS [?]TOO SMALL' BY THE SERVICE ENGINEER TO APPLY THE SPECIFIED TORQUE. DURING THE CLINICAL OPERATION OF THE DEVICE, THE SCREWS HAVE BECOME LOOSE AND THEN DETACHED DUE TO DYNAMIC LOAD-CHANGES THAT NORMALLY MUST BE EXPECTED AT APPLICATION. A RISK ASSESSMENT WAS CONDUCTED WHICH CONCLUDED THAT THE CURRENT OVERALL DESIGN OF THE DEVICE INHERITS A RISK. THE RISK WAS CLASSIFIED AS 'UNDESIRABLE'. THE ORIGINAL SCREWS SHALL BE REPLACED WITH THE HEXAPOD MOUNTING KIT 03-999-1142. (B)(4) WILL INFORM THE CUSTOMERS ABOUT THE SITUATION. THE SCREWS SHALL BE CHECKED BY THE CUSTOMER. IF ANY SCREW IS LOOSE THE SYSTEM MUST BE PUT OUT OF SERVICE. A SERVICE ENGINEER SHALL TIGHTEN THE SCREWS WITH THE SPECIFIED TORQUE. (B)(4) WILL INTRODUCE THE NEW SCREWS AS MANDATORY SAFETY MODIFICATION. BOTH (B)(4) ARE CURRENTLY BEING PREPARED. THE NEW SCREWS HAVE ALREADY BEEN INTRODUCED TO THE HEXAPOD SERIES PRODUCTION. THIS IS THE MANUFACTURER'S FINAL REPORT. DEVICE EVALUATED BY MFR: COMPLETED. CORRECTED - TICKED RECALL.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS STILL ON-GOING. ELEKTA WILL PROVIDE AN UPDATE ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THERE HAS NOT BEEN AN ADVERSE EVENT. THE CUSTOMER HAS REPORTED THAT WHEN THEY PUSHED THE TABLE TOP DOWN ON THE HEAD SIDE THERE WAS A SHIFT OF 10CM. THE SCREWS UNDER THE TABLE TOP WHICH HOLD THE HEXAPOD IN POSITION WERE UNSCREWED. THE SCREWS HAVE BEEN TIGHTENED BY THE CUSTOMER, FIXING THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178365 HEXAPOD EVO RT SYSTEM COUCH, RADIATION THERAPY, POWERED JAI MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH P10603-100

    Patients

    Seq Age Sex Outcome Treatment
    1