BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1822154 · Received December 3, 2007

    Report

    Report Number
    1527736-2007-08140
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 19, 2007
    Report Date
    November 19, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION 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 SITE REPLACED THE BLUE CABLE DUE TO IT WAS BROKEN AT THE LEMO CONNECTOR AND CAUSING NOISE PER THE COMPLAINT. THE GREEN CABLE WAS REPLACED BECAUSE IT CAUSED L3-009 ERRORS, AND THE E-CLIP WAS REPLACED DUE TO IT WAS DAMAGED DURING DISASSEMBLY. AFTER SERVICING, THE UNIT PASSED ALL QA FUNCTIONAL TESTING. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A BREAST BIOPSY THE HOLSTER WAS MAKING A SQUEAKING SOUND WHEN SAMPLES WERE TAKEN. THE CASE WAS ABLE TO BE COMPLETED WITH NO PATIENT CONSEQUENCE. ONE DEVICE TO BE RETURNED FOR ANALYSIS.

    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