BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1032238 · Received April 18, 2008

    Report

    Report Number
    1527736-2008-02283
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    May 10, 2007
    Report Date
    May 10, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE COULD NOT CONFIRM AND WAS UNABLE TO DUPLICATE THE CUSTOMER COMPLAINT OF THE BLACK CABLE ERRORS. THE ANALYSIS SITE REPLACED THE GREEN CABLE DUE TO IT WAS DAMAGED AND CAUSED THE PROBE TO LOCK UP. THE E-CLIP WAS REPLACED DUE TO IT WAS DAMAGED DURING DISASSEMBLY. AFTER SERVICING, THE UNIT PASSED QA FUNCTIONAL TESTING. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED THAT AN ERROR CODE OF THE BLACK CABLE WAS POPULATING ON THE LCD SCREEN DURING THE INITIALIZATION PRIOR TO A BREAST BIOPSY. THE CUSTOMER REPORTED THE PROBE, DURING INITIALIZATION "LOCKED-UP" INSIDE THE HOLSTER. THE BIOPSY WAS COMPLETED USING THE LOANER HOLSTER. ONE DEVICE TO BE RETURNED. THERE HAVE BEEN NO PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTOME ST HOLSTER/CABLES KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| PROBE