BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RBI2

    MDR report key: 6724062 · Received July 19, 2017

    Report

    Report Number
    3005921952-2017-00001
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    June 23, 2017
    Report Date
    July 19, 2017
    Product Code
    FCK
    PMA / PMN Number
    K062159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT RELATES TO NOTICE OF INCIDENTS FROM A SINGLE USER AT A HOSPITAL IN THE (B)(6). THE USER FAILED TO FULLY DEPRESS THE TRIGGER TO ACTIVATE THE BLADE AS PER DESCRIBED IN THE PRODUCT IFU SUPPLIED WITH THE DEVICE. THIS DEVICE HAS BEEN INCIDENT FREE WITH ALL OTHER USERS AT THE HOSPITAL SINCE ITS ORIGINAL PURCHASE 11 YEARS PRIOR. FURTHER TECHNICAL TRAINING HAS BEEN OFFERED TO THE INDIVIDUAL AND OTHER HOSPITAL STAFF AND THIS IS CURRENTLY BEING CONDUCTED. THE DEVICE REQUIRED MINOR INTERVENTION FOR REMOVAL OF THE DEVICE FROM THE SUBMUCOSA TISSUE. THE INCIDENTS DID NOT CAUSE ANY SERIOUS LONG TERM INJURY TO THE PATIENTS.

    Description of Event or Problem · 1

    SUBMUCOSA TISSUE WEDGED BETWEEN CUTTING BLADE DUE TO USER NOT FOLLOWING INSTRUCTIONS FOR USE TO FULLY DEPRESS THE DEVICE TRIGGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507178 RBI2 RBI2 SUCTION RECTAL BIOPSY SYSTEM FCK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention