BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF ABLATION SYSTEM FOOT SWITCH

    MDR report key: 1232750 · Received November 14, 2008

    Report

    Report Number
    2953184-2008-00043
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC, EP TECHNOLOGIES
    Product Code
    LPB
    PMA / PMN Number
    P020025
    Removal / Correction Number
    PIR# 90461367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECENTLY RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETED. REMEDIAL ACTION HAS BEEN INITIATED DUE TO THE PRELIMINARY INVESTIGATION INFO RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON (B)(6) 2008 THAT WHILE USING A FOOT SWITCH THE CUSTOMER EXPERIENCED THE FOLLOWING: 'DURING THE PROCEDURE, THE NURSE MOVED THE FOOT SWITCH TAKING IT WITH THE HANDS AND WITHOUT PRESSING THE SWITCH, IT DELIVERED RF ENERGY FOR ABOUT 2 SECONDS.' PRELIMINARY RESULTS FROM THE INVESTIGATION RELATED TO THE DEVICE ON MDR 2953184-2008-00041 WAS RECEIVED ON OCTOBER 17, 2008. THE INFO INDICATES A MALFUNCTION OF THE FOOTSWITCH MAY CAUSE ACCIDENTAL ACTIVATION OF RF. DUE TO THE POTENTIAL RISK TO THE PATIENT OR USER, THIS COMPLAINT IS SIMILAR AND NOW CONSIDERED A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF ABLATION SYSTEM FOOT SWITCH FOOT SWITCH LPB BOSTON SCIENTIFIC, EP TECHNOLOGIES 21840

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EPT 1000 XP GENERATOR