BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1121895 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01157
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND A LOOSE DC MOTOR ADAPTER IN THE BLUE CABLE CONNECTOR WAS CAUSING THE UNIT TO HAVE THE L3-018 ERROR CODE. THE ANALYSIS SITE REPLACED THE DC MOTOR ADAPTER TO CORRECT THE ERROR CODE. THE SITE DID NOT SEE THE ERROR L3-017 IN THE EVENT LOG NOR DURING TESTING. THE SITE ALSO FOUND THE UNIT HAS A LOUD BANGING NOISE WHEN THE VACUUM PUMP IS ACTIVATED. TO CORRECT THIS ISSUE THE ANALYSIS SITE REPLACED FOUR PUMP ISOLATION MOUNTS, FOUR FLAT WASHERS, FOUR FENDER WASHERS, AND FOUR PUMP MOUNT SCREWS TO CORRECT THE NOISE ISSUE. PER THE SERVICE MANUAL, SERVICE TEST WAS PERFORMED WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE STANDARD SERVICE PROCESS, REPLACED THE MUFFLER, APPLIED LOCTITE TO THE FOOT/HAND SWITCH CONNECTOR, APPLIED DOW CORNING LUBRICANT TO THE DC MOTORS, AND REPLACED THE HOLSTER: IF BOARD TO BEZEL. AS PER THE SERVICE MANUAL, PERFORMED THE DC MOTOR ADAPTER UPGRADE, REPLACED THE INTERNAL VACUUM TUBE CONNECTIONS WITH 90 DEGREES ELBOW, AND SHORTENED THE LENGTH OF THE TUBING ASSEMBLY. 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

    IT WAS REPORTED THAT THE HOLSTER HAD EXPOSED WIRES AND DURING A CASE ERROR CODES L3-002 AND L3-007 WERE RECEIVED. THERE WERE NO PT CONSEQUENCES REPORTED. THE CASE WAS COMPLETED USING THE HOLSTER. HOLSTER 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 PROBE| CONTROL MODULE