BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS DRIVERS

    MDR report key: 725936 · Received June 8, 2006

    Report

    Report Number
    1527736-2006-02613
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    May 24, 2006
    Report Date
    June 5, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K992813
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED UPON THE INQUIRY INFORMATION RECEIVED VISUAL AND FUNCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THE POWER CABLE TO BE REPLACED.THE DEVIE WAS FUNCTIONALLY TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER. 510(K) IS K992813

    Description of Event or Problem · 1

    THE D10LE HAS A BROKEN CUTTER GEAR KNOB. THERE HAVE BEEN NO PT CONSEQUENCES REPORTED. NO INTERRUPTIONS IN BREAST BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSYS DRIVERS KNW KNW ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN (1) PROBE| (2) CONTROL MODULE