BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1191249 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03638
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 27, 2008
    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
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE GREEN CABLE WAS DAMAGED AND EXPOSED. TO CORRECT THE COMPLAINT, THE ANALYSIS SITE REPLACED THE GREEN CABLE. THE E-CLIP WAS REPLACED DUE TO IT DAMAGED DURING DISASSEMBLY AND PER THE SERVICE MANUAL, SERVICE TEST WERE PERFORMED WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE STANDARD SERVICE PROCESS, REMOVED THE SALES FROM THE LEMO CONNECTORS, AND ADDED HEAT SHRINK TO THE GREEN AND BLUE CABLES. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT, THEREFORE NO SERVICE HISTORY REVIEW CAN BE DONE. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED THAT THE HOLSTER GAVE A GREEN CABLE ERROR DURIG INITIALIZATION DURING A BREAST BIOPSY. THE CUSTOMER TRIED A SECOND HOLSTER WITH THE SAME PROBE AND MANAGED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE. AFTER THE CASE, THE CUSTOMER NOTICED THERE WAS A CRACK IN THE CABLING FOR THE GREEN HOLSTER CABLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTOME ST HOLSTER/CABLES NONE KNW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| CONTROL MODULE