BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME ST HOLSTER

    MDR report key: 4284336 · Received November 21, 2014

    Report

    Report Number
    MW5039286
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 21, 2014
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIAGNOSIS OR REASON FOR USE: STEREOTACTIC BREAST BIOPSY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: YES. ETHICON ENDO-SURGERY MAMMOTOME ST HOLSTER USING MAMMOTOME ST MST8 STEREOTACTIC PROBES STOPPED WORKING DURING SEVERAL PROCEDURES DEMONSTRATING ERROR CODES OF "L3-017, 003, 007". THERE WAS ALSO A SUBSEQUENT "GREEN CABLE DAMAGE ERROR" OF THE AUTOGUIDE WHICH HAS RESULTED IN THE EXCHANGE OF THIS COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756779 MAMMOTOME ST HOLSTER STEREOTACTIC AUTOGUIDE KNW ETHICON ENDO-SURGERY GST021960

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR