BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANARUS CENTRICA ROTATIONAL CORE BIOPSY SYSTEM

    MDR report key: 482694 · Received September 3, 2003

    Report

    Report Number
    3003515897-2003-00002
    Event Type
    Malfunction
    Date Received
    September 3, 2003
    Date of Event
    July 28, 2003
    Report Date
    September 3, 2003
    Manufacturer
    SANARUS MEDICAL
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A FAILURE OCCURRED DURING POST-SERTILE LOT TESTING OF THE CENTRICA DEIVCE, LOT #C030704 PRIOR TO LOT RELEASE. THIS FAILURE WAS A SEPARATION OF THE HIGH-PRESSURE LINE, RESULTING IN AN EXPULSION OF ARGON GAS FROM THE DEVICE CUTTER. THIS LOT OF DEVICES NEVER REACHED COMMERCIAL DISTRIBUTION. THE DEVICE IN QUESTION WAS NOT USED IN A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS CENTRICA ROTATIONAL CORE BIOPSY SYSTEM BIOPSY INSTRUMENT KNW SANARUS MEDICAL CD0500 C030704

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other