BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPERSIVE ELECTRODE (TIN/KATECHO)

    MDR report key: 1971907 · Received January 20, 2011

    Report

    Report Number
    1056436-2011-00002
    Event Type
    Other
    Date Received
    January 20, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 18, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER IN DEPTH DISCUSSION WITH BIO-MEDICAL ENGINEER, DOC PERFORMING THE CASE AND THE NURSE IT APPEARS THAT THE PROCEDURE WAS DONE FOLLOWING THE OPERATIVE INSTRUCTIONS. IT WAS A COLO RECTAL LIVER METS OF 3.5 MM IN A MALE PT. STARBURST XL PROBE WAS OPEN TO 5 CM. PROCEDURE LASTED 30 MINUTES WITH 3 SHOTS IN TOTAL. PT WAS NOT SHAVED BEFORE THE PROCEDURE. THE PADS WERE PLACED ACCORDING TO OUR DFU. DURING THE PROCEDURE, THE DOC AND NURSE SMELT SOME BURN ODOURS (ODORS), BUT AFTER MANUALLY CHECKING THE TEMPERATURE ON THE PADS, DIDN'T NOTICE ANY HEAT AND DECIDED TO CONTINUE THE PROCEDURE. AFTER THE END OF THE PROCEDURE AND WHEN REMOVING THE PADS, THEY NOTICED SEVERE 3 DEGREES SKIN BURNS ON BOTH PT TIGHTS. THEY REPORTED THAT BEFORE THE PROCEDURE, WHEN THEY REMOVED THE WHITE PEEL AWAY PROTECTIVE SHEET ON THE KATECHO GROUNDING PADS, THE GEL CAME AWAY AND PART OF IT STAYED STUCK ON THE PROTECTIVE SHEET. IT APPEARS THAT ON ANOTHER KATECHO GROUNDING PADS THEY GOT IN STOCK, WE TRIED TO REMOVE THE PEEL AWAY SHEET AND THE GEL CAME WITH IT AS WELL. LEAVING THE GROUNDING PADS WITHOUT GEL ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPERSIVE ELECTRODE (TIN/KATECHO) DISPERSIVE ELECTRODE (TIN/KATECHO) GEI ANGIODYNAMICS NA Y081809-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other