BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSYS DRIVERS

    MDR report key: 725914 · Received June 7, 2006

    Report

    Report Number
    1527736-2006-02609
    Event Type
    Malfunction
    Date Received
    June 7, 2006
    Date of Event
    May 19, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H3: BASED UPON THE INQUIRY INFORMATION RECEIVED, VISUAL AND FUNCTIONAL EXAM, THE DRIVER WAS RETURNED WITH A DAMAGED CABLE CAUSING THE DRIVER TO HAVE INTERMITTENT VACUUM WHEN ACTIVATED. REPLACED THE POWER CABLE TO CORRECT THE COMPLAINT. THE DRIVER WAS TESTED AND MET PRODUCT SPECIFICATIONS. 510K NUMBER IS K992813.

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING A BREAST BIOPSY AND NOTICED THE VACUUM WAS ACTIVATING INTERMITTENTLY AND THE CABLE TO THE DRIVER WAS FRAYED. CASE COMPLETED WITH NO PT CONSEQUENCE.

    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 PROBE| CONTROL MODULE