BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRE SINGLE ELECTRODE PROBE

    MDR report key: 1657895 · Received April 7, 2010

    Report

    Report Number
    1319211-2010-00013
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 31, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE LOT NUMBER WAS NOT PROVIDED. A SHIP HISTORY SHOWED THAT THE FOLLOWING LOT HAD BEEN SHIPPED IN THE LAST 6 MONTHS: (B)(4). THE COMPLAINT INFO WAS FORWARDED TO PRONET. PRONET REVIEWED THE POSSIBLE LOT HISTORY RECORDS AND FOUND NO VARIANCES RELATED TO THIS EVENT WERE OBSERVED. REVIEW OF RETURNED SAMPLE: CONFIRMED THE REPORTED COMPLAINT. CONCLUSION: THE COMPLAINT SAMPLE HAS BEEN SENT TO THE VENDOR FOR FURTHER EVAL. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    DURING IRE DELIVERY FOR THE INITIAL AND FIRST PULL BACK, POPPING NOISES WERE AUDIBLE. WHEN DR. (B)(6) PULLED BACK AGAIN, THE POPPING NOISES SOUNDED MORE LIKE MUFFLED ARCING, HOWEVER, THERE WAS NO HIGH CURRENT CONDITIONS. DURING THE 5TH PULL BACK, DR. (B)(6) NOTICED SMALL SPARKS COMING FROM ONE OF THE NEEDLES AT THE SURFACE OF THE SKIN. CLOSE INSPECTION OF THE DEVICE REVEALED WHAT LOOKS TO BE A SLICE INTO THE INSULATION HALF WAY UP THE INSULATION.

    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 64 YR