BEUDAMED
    FDA Adverse Event Other Summary report: N

    AED SUCTION/IRRIGATION ELECTRODE

    MDR report key: 2494106 · Received March 9, 2012

    Report

    Report Number
    1722040-2012-00001
    Event Type
    Other
    Date Received
    March 9, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 14, 2012
    Manufacturer
    ENCISION INC
    Product Code
    GEI
    PMA / PMN Number
    K100711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAD BEEN WELL MAINTAINED AND WAS IN EXCELLENT WORKING ORDER WHEN RETURNED. THE DESIGN OF THIS DEVICE HAS BEEN USED FOR YEARS AND HAS BEEN ALWAYS BEEN COMPATIBLE WITH THIS MODEL AND SIZE OF TROCAR WITHOUT SIMILAR INCIDENT. FROM WHAT THE SURGEON REPORTED AN APPARENT UNEXPECTED LEVEL OF FRICTION BETWEEN THE INSTRUMENT AND THE TROCAR IN WHICH IT WAS BEING INSERTED, DUE TO THE CHARACTERISTICS OF THE TROCAR, COMBINED WITH THE WEIGHT OF THE CORD ATTACHED TO THE INSTRUMENT LED THE SURGEON TO APPLY ENOUGH FORCE TO OVERCOME THE SHIELD'S DETENT AND RETRACT THE SHIELD AS THE INSTRUMENT WAS BEING ADVANCED, RESULTING IN EXPOSING THE ORGAN TO THE ELECTRODE TIP PREMATURELY.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT THE DESIGN CHARACTERISTICS OF THE INSTRUMENT, ALONG WITH ITS SHEATH NOT SLIDING SMOOTHLY WITHIN THE TROCAR DURING A LAPAROSCOPIC CHOLECYSTECTOMY (GALLBLADDER REMOVAL), LED TO THE ELECTRODE PREMATURELY EMERGING FROM ITS SHEATH; PIERCING THE GALLBLADDER. WHILE NO HARM WAS DONE TO THE PT, AS THE GALLBLADDER WAS BEING REMOVED ANYWAY, HAD A DIFFERENT BODY STRUCTURE BEEN INVOLVED THE INJURY MIGHT HAVE BEEN SERIOUS. CHARACTERISTICS CITED BY SURGEON INCLUDED BULKY NATURE OF ELECTROSURGICAL CORD, THE WAY THE SHEATH SLIDES BACK AND FORTH, AND THE TIP NOT BEING CURVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED SUCTION/IRRIGATION ELECTRODE ELECTROSURGICAL DEVICE GEI ENCISION INC SPATULA ELECTRODE RL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other