BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RBI2

    MDR report key: 5226889 · Received November 16, 2015

    Report

    Report Number
    3005921952-2015-00001
    Event Type
    Injury
    Date Received
    November 16, 2015
    Date of Event
    February 13, 2013
    Report Date
    November 12, 2015
    Product Code
    FCK
    PMA / PMN Number
    K062159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RETROSPECTIVE REPORT TO INCLUDE EVENT ON THE DATABASE. DISCUSSION WITH USER AND HEAD OF DEPARTMENT AT TIME OF INCIDENT REVEILED THAT THE USER HAD KNOWINGLY IGNORED THE SUCTION LEVELS AS PER ON THE PRODUCT IFU SUPPLIED WITH DEVICE. THE USER USED 400% ADDITIONAL SUCTION THAN MANUFACTURER'S INSTRUCTIONS FOR USE. EXCESSIVE SUCTION CAUSED A VERY LARGE BIOPSY TO BE TAKEN CAUSING PERSISTENT BLEEDING FROM THE BIOPSY SITE. A SINGLE STITCH WAS USED TO CLOSED THE BIOPSY SITE WHICH STOPPED THE BLEEDING AND THE PATIENT DID NOT HAVE ANY FURTHER EFFECT FROM THIS INCIDENT. THE IFU CLEARLY STATES THE AMOUNT OF SUCTION TO USE AND WARNS AGAINST USING EXCESSIVE SUCTION.

    Description of Event or Problem · 1

    OVERSIZED RECTAL BIOPSY SPECIMEN TAKEN DUE TO USER ERROR WITH INCORRECT SUCTION LEVEL USED. USER STATED THAT THEY PURPOSELY IGNORED THE RECOMMENDED SUCTION LEVEL ON THE COMPANIES IFU SUPPLIED WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758688 RBI2 RBI2 SUCTION RECTAL BIOPSY SYSTEM FCK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention