BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2902307 · Received January 8, 2013

    Report

    Report Number
    9612355-2013-00002
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE STOCKERT FOOT PEDAL BECAME STUCK IN THE DOWN (ON) POSITION DURING AN AFIB PROCEDURE. THE FOOT PEDAL WAS UNPLUGGED FROM THE STOCKERT TO STOP ABLATION. A REPLACEMENT FOOT PEDAL WAS CONNECTED AND FUNCTIONED NORMALLY. THERE WAS NO PATIENT INJURY. A FOOT PETAL WAS REPLACED AND THE UNIT WAS FUNCTIONING PER SPECIFICATION. THE DEVICE HISTORY RECORD FOR STOCKERT GENERATOR SERIAL NUMBER ST-0891 SHOWS THAT NO MANUFACTURING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO FUNCTIONALITY OF THE DEVICE. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION. CUSTOMER'S COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS REPORTED THAT THE STOCKERT FOOT PEDAL BECAME STUCK IN THE DOWN (ON) POSITION. THE FOOT PEDAL WAS UNPLUGGED FROM THE STOCKERT TO STOP ABLATION. ISSUE WAS RESOLVED AFTER THE FOOT PEDAL WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9679 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1