BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATOME STEREOTACTIC 11 G PROBE

    MDR report key: 1822183 · Received October 9, 2007

    Report

    Report Number
    1527736-2007-06700
    Event Type
    Malfunction
    Date Received
    October 9, 2007
    Report Date
    May 24, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE MST11 INSTRUMENTS FOUND THAT THEY WERE RETURNED IN GOOD CONDITION AND OUT OF THEIR STERILE PACKAGE. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE FINDING. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN TWO BOXES OF PROBES ARRIVED AT THE FACILITY THE TYVECS WERE NOT SEALED. THIS WAS THE CASE ON ALL 10 PROBES. NO CASE INVOLVEMENT. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATOME STEREOTACTIC 11 G PROBE KNW ETHICON ENDO-SURGERY, INC (CINCINNATI) NA C4FP49

    Patients

    Seq Age Sex Outcome Treatment
    1