BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC

    MDR report key: 1033386 · Received April 23, 2008

    Report

    Report Number
    MW5006365
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. , JOHNSON AND JOHNSON
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ETHICON PILLAR AND POST LOCALIZATION SYSTEM WERE USED TO TARGET THE POSTERIORLY LOCATED 15 MM BREAST LESION. THE TROCAR WAS ADVANCED IN STANDARD FASHION TO THE REGION OF THE MASS THROUGH THE SHEATH. ADD'L IMAGES WERE PERFORMED AND DEMONSTRATED THAT THE SAMPLING APERTURE WAS APPROX 1.0 CM ANTEROMEDIAL FROM THE INTENDED SITE. THE Z SCREW WAS ROTATED CLOCKWISE 5 ROTATIONS TO ALLOW FOR 1 CM ADD'L ADVANCEMENT. THE TROCAR WAS ADVANCED IN STANDARD FASHION BUT EXTENDED APPROX 4 CM POSTEROMEDIAL TO THE INTENDED SITE DUE TO Z STOP FAILURE. ADD'L IMAGING CONFIRMED THAT THE SAMPLING APERTURE WAS NOT AT THE TARGETED LESION. THE TIP OF THE NEEDLE WAS ADJACENT TO THE EXTREME ANTERIOR ASPECT OF THE STERNUM. THE TROCAR AND SHEATH WERE REMOVED, AND MANUAL COMPRESSION WAS APPLIED. HEMOSTASIS WAS ACHIEVED. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: BREAST MASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC PILLAR AND POST MRI BREAST BIOPSY DEVICE IZH ETHICON ENDO-SURGERY, INC. , JOHNSON AND JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR