BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1082928 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00681
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 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
    CT, US
    Reporter Occupation
    OTHER

    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 OF "TRIANGLE SYMBOL UPON ACTIVATING THE CUTTER" AND FOUND THE TRANSLATIONAL AND ROTATIONAL CABLES WERE DAMAGED. TO CORRECT THIS ISSUE THE ANALYSIS SITE REPLACED THE TRANSLATIONAL AND ROTATIONAL CABLES. 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 A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED GETTING A TRIANGLE SYMBOL UPON ACTIVATING THE CUTTER IN POSITIONING MODE AND THE SAMPLE MODE. THE SYMBOL REPORTED IS AS A RESULT OF TOO MUCH TORQUE ON THE CABLES, AND IS PRECURSOR TO GETTING ERROR CODES. 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, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| PROBE