BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1181737 · Received September 30, 2008

    Report

    Report Number
    3005075853-2008-01996
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE UNIT WAS RECEIVED WITH MINOR SCRATCHES. BASED UPON THE INQUIRY INFORMATION RECEIVED, VISUAL AND FUNCTIONAL EXAMINATION, THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. TO CORRECT THE ISSUE, THE ANALYSIS SITE REPLACED THE PORT SHAFT AND THE COCKING LEVER. ADDITIONAL PARTS REPLACED THAT WERE UNRELATED TO THE CUSTOMER COMPLAINT WERE THE ENCODER, FORK SCREW, PCB ASSEMBLY, SAFETY LATCH AND THE ROTATIONAL AND ELECTRICAL CABLES. AFTER SERVICING, THE UNIT PASSED ALL QA TESTING PROCESS. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE COCKING LEVER IS BENT AND THE ROTATION KNOB IS LOOSE ON THE HOLSTER. NO CASE OR PATIENT INVOLVEMENT. ONE DEVICE IS BEING RETURNED FOR REPAIR.

    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