BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANARUS CASSI II

    MDR report key: 1895338 · Received November 2, 2010

    Report

    Report Number
    3008087395-2010-00006
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    SANARUS TECHNOLOGIES LLC
    Product Code
    KNW
    PMA / PMN Number
    K042136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT THE DEVICE POWER WAS NOT STRONG ENOUGH TO CUT THROUGH TISSUE. THE PROCEDURE WAS NOT COMPLETED; PT LEFT WITH NO BIOPSY SAMPLES TAKEN AS A BACKUP DEVICE WAS NOT AVAILABLE. PT WILL BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS CASSI II CASSI II 10 GAUGE NEEDLE KNW SANARUS TECHNOLOGIES LLC CS2100-NT-1 C2100602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention