BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOTOME EX PROBE AND VACUUM SET - 11 GA

    MDR report key: 1387209 · Received May 15, 2009

    Report

    Report Number
    3005075853-2009-02851
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    April 20, 2009
    Report Date
    April 20, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    KNW
    PMA / PMN Number
    K033700
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE A WAS RETURNED IN GOOD PHYSICAL CONDITION. THE PROBE WAS CONNECTED TO A TEST HOLSTER AND CONTROL MODULE, INITIALIZED, VACUUMED AND FUNCTIONED PROPERLY. THE CUTTING FEATURE OF THE INSTRUMENT WAS EVALUATED WITH A TEST MEDIA AND IT CUTS AS INTENDED. THE PROBE WAS FULLY FUNCTIONAL AND CONFORMING TO MANUFACTURING REQUIREMENTS. WHILE WE WERE UNABLE TO RE-CREATE THE EVENT, 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 DEVICE B WAS RETURNED IN GOOD PHYSICAL CONDITION. THE PROBE WAS CONNECTED TO A TEST HOLSTER AND CONTROL MODULE, INITIATED, VACUUMED AND FUNCTIONED PROPERLY. THE CUTTING FEATURE OF THE INSTRUMENT WAS EVALUATED WITH A TEST MEDIA AND IT CUTS AS INTENDED, THE PROBE WAS FULLY FUNCTIONAL AND CONFORMING TO MANUFACTURING REQUIREMENTS. WHILE WE WERE UNABLE TO RE-CREATE THE EVENT, 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND HELD BREAST PROCEDURE, THE DEVICE DID NOT CUT, A SECOND PROBE WAS OPENED AND IT WOULD NOT CUT. AT THIS POINT THE SURGEON DECIDED TO ABORT THE PROCEDURE, AND THE PATIENT RECEIVED A CORE BIOPSY. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME EX PROBE AND VACUUM SET - 11 GA KNW ETHICON ENDO-SURGERY, LLC NA F4N51A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention