BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1162306 · Received September 8, 2008

    Report

    Report Number
    3005075853-2008-01575
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Report Date
    June 30, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THE COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE UNIT WAS RETURNED TO THE INTERNATIONAL SERVICE CENTER. BASED UPON THE INQUIRY INFO RECEIVED, VISUAL AND FUNCTIONAL EXAMINATION, THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. THE ROTATIONAL CABLE WAS REPLACED TO CORRECT THE ISSUE. ALSO REPLACED WAS THE FOLLOWING: UPPER CASE, FASTENING MATERIAL AND THE UNDERHOUSING. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED VIA THE DATABASE. THE UNIT HAS PASSED ALL QA INSPECTIONS. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SERVICE CENTER THAT THE UNIT WAS SENT TO THEM FOR REPAIR, BECAUSE THE HOLSTER DOES NOT OPERATE ANYMORE. IT WAS NOT NOTED IF THE ISSUE OCCURRED DURING A PROCEDURE. NO PT CONSEQUENCE 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