BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANARUS CASSI ROTATIONAL CORE BIOPSY SYST

    MDR report key: 620761 · Received July 11, 2005

    Report

    Report Number
    3003515897-2005-00005
    Event Type
    Malfunction
    Date Received
    July 11, 2005
    Date of Event
    June 10, 2005
    Report Date
    July 11, 2005
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PREPPING THE CASSI ROTATIONAL CORE BIOPSY DEVICE FOR USE BY TURNING THE CO-2 CANISTER TO ACTIVATE THE DEVICE. UPON TURNING THE DEVICE, THE PHYSICIAN REPORTED THAT THE DEVICE CHANNIS SPLIT ALONG THE SEAM. THE DEVICE WAS NOT USED IN A PT. THERE WAS NO PT INJURY, NOR ANY USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS CASSI ROTATIONAL CORE BIOPSY SYST BIOPSY INSTRUMENT KNW SANARUS MEDICAL, INC. CS1000 CS50205

    Patients

    Seq Age Sex Outcome Treatment
    1 NA