BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPT-1000XP? RF ABLATION SYSTEM - FOOT SWITCH

    MDR report key: 3179545 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04138
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    PLEXUS SERVICES CORPORATION
    Product Code
    OAD
    PMA / PMN Number
    P020025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOOT SWITCH WAS RECEIVED BACK WITH THE OUTSIDE GUARD BENT OUT OF SHAPE. THERE WAS A DENT ON THE TOP RIGHT REAR SIDE OF THE OUTSIDE GUARD. THERE WERE SOME PAINT CHIPS ALONG THE EDGES OF THE OUTSIDE GUARD ON THE FRONT AND BACK SIDES. THE REST OF THE DEVICE WAS IN OVERALL GOOD PHYSICAL SHAPE. THE PLASTIC PEDAL PRESSED DOWN EVENLY. THE CONNECTOR AND PINS WERE CLEAN AND ALIGNED PROPERLY. THE FOOT SWITCH WAS FUNCTIONALLY TESTED; THE FOOTSWITCH WAS ACTIVATED AND RELEASED SEVERAL TIMES. EACH TIME THE UNIT STARTED AND MAINTAINED AN ABLATION CYCLE WITH NO ERRORS. WHEN THE FOOT SWITCH PEDAL WAS RELEASED, THE ABLATION CYCLE ENDED. THE FOOT SWITCH CABLE WAS PULLED AND TWISTED IN SEVERAL WAYS TO TEST FOR SHORTS IN THE INTERNAL WIRING. THE EPT-1000 GENERATOR REMAINED IN READY MODE WITH NO UNINTENDED RF DELIVERY ACTIVATION. THE FOOT SWITCH CABLE WAS WIGGLED AT THE STRAIN RELIEF EXITING THE FOOT PEDAL TO TEST FOR SHORTS IN THE INTERNAL WIRING. THE EPT-1000 GENERATOR REMAINED IN READY MODE WITH NO UNINTENDED RF DELIVERY ACTIVATION. THE FOOT SWITCH CABLE WAS WIGGLED AT THE STRAIN RELIEF OF THE CONNECTOR ENTERING THE GENERATOR¿S RECEPTACLE TO TEST FOR SHORTS IN THE INTERNAL WIRING. THE EPT-1000 GENERATOR REMAINED IN READY MODE WITH NO UNINTENDED RF DELIVERY ACTIVATION. THE FOOT SWITCH CABLE WAS PULLED AND TWISTED IN SEVERAL WAYS TO TEST FOR BREAKS IN THE INTERNAL WIRING. THE EPT-1000 GENERATOR MAINTAINED THE ABLATION CYCLE. THE FOOT SWITCH CABLE WAS WIGGLED AT THE STRAIN RELIEF EXITING THE FOOT PEDAL TO TEST FOR BREAKS IN THE INTERNAL WIRING. THE EPT-1000 GENERATOR MAINTAINED THE ABLATION CYCLE. THE FOOT SWITCH CABLE WAS WIGGLED AT THE STRAIN RELIEF OF THE CONNECTOR ENTERING THE GENERATOR¿S RECEPTACLE TO TEST FOR BREAKS IN THE INTERNAL WIRING. THE EPT-1000 GENERATOR MAINTAINED THE ABLATION CYCLE. THE FOOT SWITCH CONNECTOR BODY WAS IN GOOD PHYSICAL CONDITION. THE GROUNDING SHIELD WAS TIGHTLY IN PLACE. THE CONNECTOR WIRES WERE SOLDERED SECURELY AND THE STRAIN RELIEF WAS IN GOOD SHAPE. THE FOOT SWITCH FUNCTIONED AS INTENDED. THERE WAS NO INDICATION OF THE REPORTED COMPLAINT DURING TESTING OF THE FOOT SWITCH. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION TREATMENT PROCEDURE, A FOOT SWITCH MALFUNCTION OCCURRED. DURING AN UNKNOWN TIME IN THE PROCEDURE THE FOOT SWITCH OF THE EPT 1000XP RF ABLATION SYSTEM DELIVERED RADIOFREQUENCY TO THE CONSOLE WITHOUT ENGAGING THE FOOT SWITCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION TREATMENT PROCEDURE, A FOOT SWITCH MALFUNCTION OCCURRED. DURING AN UNKNOWN TIME IN THE PROCEDURE THE FOOT SWITCH OF THE EPT 1000XP RF ABLATION SYSTEM DELIVERED RADIOFREQUENCY TO THE CONSOLE WITHOUT ENGAGING THE FOOT SWITCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280660 EPT-1000XP? RF ABLATION SYSTEM - FOOT SWITCH CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD PLEXUS SERVICES CORPORATION M0048400 012706-057

    Patients

    Seq Age Sex Outcome Treatment
    1