BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1834595 · Received December 13, 2007

    Report

    Report Number
    1527736-2007-08481
    Event Type
    Malfunction
    Date Received
    December 13, 2007
    Date of Event
    November 26, 2007
    Report Date
    November 27, 2007
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY - BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND TO CORRECT THE COMPLAINT THE BLUE ROTATIONAL CABLE AND THE GREEN TRANSLATIONAL WERE REPLACED. ALSO REPLACED WERE THE FOLLOWING: PORT SHAFT, RETAINING RING, SPUR GEAR AND COIL PIN. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT, THEREFORE NO SERVICE HISTORY REVIEW CAN BE DONE. AFTER SERVICING THE UNIT PASSED ALL QA FUNCTIONAL TESTING. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNK PROCEDURE THE INSTRUMENTS CANNOT TURN. NO PT CONSEQUENCES WERE REPORTED. THE HOLSTER WILL BE RETURNED TO THE INTERNATIONAL SERVICE CENTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| PROBE