BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11G BLADED MAMMOTOME ST PROBE

    MDR report key: 1021976 · Received March 18, 2008

    Report

    Report Number
    1527736-2008-01642
    Event Type
    Injury
    Date Received
    March 18, 2008
    Report Date
    February 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/18/2008. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A BREAST BIOPSY IN 2006. SHE ALLEGED, THAT SHE WAS INFECTED WITH THE HEPATITIS C VIRUS. A BLOOD TEST PERFORMED PRIOR TO THE BIOPSY AND DID NOT SHOW HEPATITIS C INFECTION. APPROX ONE-MONTH POST BIOPSY, THE PT UNDERWENT A BREAST NEOPLASM REMOVAL PROCEDURE. SOME DAYS AFTER THE PROCEDURE, A BLOOD TEST WAS PERFORMED; SHOWED THAT THE PT WAS INFECTED WITH THE HEPATITIS C VIRUS. ALLEGEDLY, AS VERY FEW DAYS PASSED FROM THE TUMOR REMOVAL SURGERY TO THE OUTBREAK OF THE VIRUS, IT IS LIKELY THAT THE VIRUS OUT BROKE BEFORE THE SURGERY. OUR SALES REP WAS INTERVIEWED BY THE JUDICIARY AUTHORITY IN ORDER TO EXPLAIN TO THEM HOW THE BREAST BIOPSY HAS TO BE PERFORMED AND EXPLAINED TO THEM THAT ALL THE DEVICES USED ARE PROVIDED STERILE AND ARE SINGLE-USE, AS REPORTED IN THE INSTRUCTION FOR USE. THERE WAS ONE OTHER PT THAT UNDERWENT A BREAST BIOPSY ON THE SAME DAY AND SHE WAS NOT INFECTED BY HEPATITIS C, VIRUS THUS NO PATIENT-TO-PATIENT CONTAGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11G BLADED MAMMOTOME ST PROBE KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA C4E46M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MARKER| CONTROL MODULE| HOLSTER