BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTOME ST HOLSTER/CABLES

    MDR report key: 1160589 · Received September 11, 2008

    Report

    Report Number
    3005075853-2008-01657
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 28, 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

    EVALUATION SUMMARY: THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT. TO CORRECT THE ISSUE, THE ANALYSIS SITE REPLACED THE ROTATIONAL CABLE AND FIRING LEVER. PART REPLACED THAT WAS UNRELATED TO THE CUSTOMER COMPLAINT WAS THE SAFETY LATCH. AFTER SERVICING, THE UNIT PASSED ALL QA TESTING PROCESSES. COMPLAINT INFORMATION 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, AS THEY TRIED TO COCK THEIR HOLSTER, THE PAD ON THE LEFT BROKE OFF. THEY ATTEMPTED TO TAKE SAMPLES THEN RECEIVED THE L3-015 ERROR CODE. THEY CHANGED PROBES TOOK ADDITIONAL SAMPLES, THEN RECEIVED THE L3-018 ERROR CODE. THEY COMPLETED THE CASE WITH NO CONSEQUENCE TO THE PATIENT.

    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