BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MST8 FINAL ASSY JRZ

    MDR report key: 864786 · Received June 13, 2007

    Report

    Report Number
    1527736-2007-04098
    Event Type
    Injury
    Date Received
    June 13, 2007
    Date of Event
    May 17, 2007
    Report Date
    May 22, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K003297
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS PERFORMING A BREAST BIOPSY PROCEDURE AND WASN'T ABLE TO ATTAIN THE NEEDED CALCIFICATIONS AT THE SITE WITHIN THE BREAST. THE DOCTOR DECIDED TO PHYSICALLY MOVE THE PROBE 2 MM IN THE X DIRECTION TO THE LATERAL ASPECT OF THE BREAST. THIS FORMED A TEAR IN THE INCISION OF THE BREAST. THE CASE WAS ABORTED AND THE PT REQUIRED STITCHES TO CLOSE THE INCISION. ACCOUNT REPORTED, IT WAS TECHNIQUE RELATED, SOME SAMPLES WERE OBTAINED, BUT THEY WERE TRYING TO OBTAIN ADD'L SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST8 FINAL ASSY JRZ KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention CONTROL MODULE| HOLSTER