BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1162319 · Received September 8, 2008

    Report

    Report Number
    3005075853-2008-01586
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE AN MDR MALFUNCTION. THE CUSTOMER COMPLAINT HAS BEEN CONFIRMED. TO CORRECT THE ERROR CODE, THE BLUE ROTATIONAL CABLE WAS REPLACE. ALSO REPLACED WAS THE TOP AND BOTTOM FRAME, SAFETY LATCH, TRANSMISSION CLAMP AND THE CUSTOM COIL PIN. AFTER SERVICING, THE UNIT PASSED ALL QA INSPECTIONS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED VIA THE DATABASE. 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 CUSTOMER STATING THAT DURING A BREAST BIOPSY PROCEDURE, THEY KEPT RECEIVING A CABLE ERROR CODE (NO CODE NOTED). THEY CHANGED PROBES AND COMPLETED THE CASE WITH NO CONSEQUENCE TO THE PT.

    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