BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1083028 · Received July 23, 2008

    Report

    Report Number
    3005075853-2008-00654
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 UNIT DISPLAYED MULTIPLE GREEN AND BLUE CABLE ERRORS DUE TO THE TRANSLATIONAL AND ROTATIONAL CABLES. TO CORRECT THE CUSTOMER COMPLAINT, THE ANALYSIS SITE REPLACED THE TRANSLATIONAL AND ROTATIONAL CABLE. THE PORT SHAFT AND COIL PIN WAS REPLACED DUE TO 'IT WAS BENT', THE SAFETY LATCH WAS REPLACED DUE TO 'IT WAS WORN', AND THE SPUR GEAR WAS REPLACED DUE TO THE TEETH ON THE SPUR GEAR BEING WORN. HEAVY CORROSION ON THE UNIT CAUSED THE FIRING MECHANISM AND THE MANUAL SPADE ASSEMBLY TO RUST. TO CORRECT THIS ISSUE, THE ANALYSIS SITE REPLACED THE FIRING MECHANISM AND THE MANUAL SPADE ASSEMBLY. THE E-CLIP WAS REPLACED DUE TO 'IT WAS DAMAGED DURING DISASSEMBLY'. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON ARE REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOLSTER WAS GIVING A GREEN CABLE ERROR CODE DURING SAMPLING MODE DURING A BREAST BIOPSY. THE CABLING WASN'T TWISTED/BRAIDED ON ITSELF AND THE CONNECTIONS WERE SEATED TIGHTLY BUT IT WAS NOTICED THE GREEN CABLING WAS FRAYED. THE ERROR WAS BYPASSED AND THE CASE WAS COMPLETED WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTOME ST HOLSTER/CABLES KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| PROBE