BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHCER CONE BIOPSY EXCISOR

    MDR report key: 742944 · Received July 21, 2006

    Report

    Report Number
    1221923-2006-00002
    Event Type
    Malfunction
    Date Received
    July 21, 2006
    Date of Event
    May 18, 2006
    Report Date
    July 20, 2006
    Manufacturer
    APPLE MEDICAL CORP.
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FCBE DESIGN HAS BEEN VALIDATED BY TESTING TO THE 2 STANDARDS THAT COVER ELECTROSURGICAL UNITS (ESUS) AND THEIR ACCESSORIES; ANSI/AAMI HF18 AND IEC 60601-2-2. IN ADDITION, EACH FCBE UNDERGOES A TOP ASSEMBLY VALIDATION HYPOT TEST. THE DIRECTIONS FOR USE (DFU) FOR THE FCBE PRESCRIBES ESU SETTINGS THAT ARE BASED ON DEVICE DESIGN. HOWEVER, IF THE FCBE IS OPERATED UNDER CONDITIONS THAT EXCEED THE DESIGN BASIS, OR BY USERS NOT ADEQUATELY TRAINED, THE FCBE MAY FAIL IN A MANNER CONSISTENT WITH THIS REPORTED FAILURE. OPERATION BEYOND THE DESIGN BASIS MAY BE INTENTIONAL OR UNINTENTIONAL DUE TO A FAULTY OR OUT OF CALIBRATION ESU. THE CIRCUMSTANCES OF THIS EVENT HOWEVER SUGGEST THAT INEXPERIENCE IN THE USE OF THE FCBE DEVICES MAY HAVE CONTRIBUTED TO THE EVENT. APPLE MEDICAL WILL IN-SERVICE THE FANNIN FACILITY IN THE PROPER USE OF THE FCBE.

    Description of Event or Problem · 1

    CARMEL OF FANNIN SURGICARE CALLED APPLE MEDICAL TO REPORT THE MALFUNCTION OF 3 FISCHER CONE BIOPSY EXCISROS (FCBE'S), A DEVICE MFR'D BY APPLE. CARMEL REPORTED THAT "WE'VE HAD THE WIRES BREAK ON 2 OF THE FISCHER PRODUCT" WHILE IN USE DURING A PROCEDURE. ONE FCBE WAS ALSO REPORTED TO BE "STICKING IN THE PENCIL". SHE REPORTED THAT THEIR "EXPERIENCED USER", DR. IRWIN, HAS HAD NO PROBLEMS. BUT NEW USERS ARE EXPERIENCING PROBLEMS, LIKE WIRES BREAKING. CARMEL STATED THAT A VALLEYLAB FORCE-TX ESU WAS BEING USED AT A SETTING OF 50 WATTS IN "CUT" MODE. CARMEL REPORTED THAT NO PT INJURIES HAVE OCCURRED AND THAT THERE WAS NO PART OR PIECE OF THE FAILED ELECTRODE LEFT IN THE PT. AN APPLE MEDICAL SALES REP WILL BE DISPATCHED TO THE FANNIN FACILITY TO CONTINUE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISHCER CONE BIOPSY EXCISOR BIOPSY INSTRUMENT KNW APPLE MEDICAL CORP. MEDIUM/LARGE SHALLO I265L/H235O

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN