BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRE SINGLE ELECTRODE PROBE

    MDR report key: 1690035 · Received May 7, 2010

    Report

    Report Number
    1319211-2010-00019
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    February 1, 2010
    Report Date
    May 4, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE EXACT CAUSE OF THE COMPLAINT IS UNK. IT IS POSSIBLE THE MOVEMENT OF THE PROBES WAS CAUSED DUE TO RESPIRATION OR CABLE WEIGHT. THIS IS THE FIRST REPORTED COMPLAINT OF THIS TYPE. THE EXACT CAUSE OF THE COMPLAINT IS UNK. DURING THE REVIEW OF THE MANUFACTURING RECORDS FOR THE POSSIBLE LOTS, IT WAS OBSERVED THAT THE MANUFACTURED LOTS MEET ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS. THIS TYPE OF COMPLAINT IS BEING EVALUATED BY OUR ENGINEERING GROUP. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    DURING THE PULSE DELIVERY, DR. (B)(6) NOTICED THAT TWO OF THE FOUR NEEDLES WERE PULLING BACK DUE TO EITHER RESPIRATION OR CABLE WEIGHT. THE TWO PROBES PULLED BACK ROUGHLY 2CM. IRE TREATMENT WAS PAUSED MID DELIVERY. DR. (B)(6) PERFORMED ADDITIONAL CT SCANS TO VISUALIZE PROBE LOCATION PRIOR TO ADVANCING BACK INTO PLACE. PROBES WERE RE-POSITIONED. PT WAS RE-SCANNED TO CONFIRM NEEDLE PLACEMENT. IRE TREATMENT WAS CONTINUED. POST CT SHOWED EDEMA IN THE AREA OF THE PROBE RE-TRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRE SINGLE ELECTRODE PROBE IRE SINGLE ELECTRODE PROBE OHJ ANGIODYNAMICS NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR