BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSI II MODEL S BIOPSY DEVICE

    MDR report key: 1865194 · Received September 29, 2010

    Report

    Report Number
    3008087395-2010-00005
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 22, 2010
    Manufacturer
    SANARUS TECHNOLOGIES, LLC
    Product Code
    KNW
    PMA / PMN Number
    K042136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN RETRIEVED PARTIAL SAMPLES FOR THE FIRST TWO BIOPSY PASSES. ON THE THIRD PASS, THE CLINICIAN HEARD CO2 VENTING AND THE CUTTING CANNULA DID NOT ADVANCE. THE PHYSICIAN SUSPECTED CANCER AND SENT THE PT TO THE HOSPITAL FOR ANOTHER BIOPSY. HOSPITAL BIOPSY CONFIRMED THE CANCER. LATER, THE PATHOLOGY REPORT FOR THE FIRST BIOPSY SAMPLES INDICATED NO CANCER. CLINICIAN BELIEVES THAT IT IS BECAUSE, THERE WAS INSUFFICIENT TISSUE FOR PATHOLOGY TO MAKE AN ACCURATE DIAGNOSIS. THE CLINICIAN STATED THAT THERE WAS NO PT COMPLICATION AS THE PHYSICIAN WAS ALREADY CERTAIN THAT THE LESION WAS CANCEROUS AND WAS ALREADY INTENDING TO SEND THE PT TO THE HOSPITAL FOR A F/U BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASSI II MODEL S BIOPSY DEVICE CASSI II ROTATIONAL CORE BIOPSY DEVICE KNW SANARUS TECHNOLOGIES, LLC MODEL S SC100201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention