BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XODUS REUSABLE SAFETY SCALPEL

    MDR report key: 6245224 · Received January 12, 2017

    Report

    Report Number
    6245224
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 11, 2017
    Manufacturer
    XODUS MEDICAL, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER ATTACHING THE #15 SAFETY BLADE TO BLADE HANDLE, ATTEMPTED TO RETRACT YELLOW SAFETY MECHANISM; UNABLE TO RETRACT. SAFETY BLADE DEVICE REQUIRES FORCE IN A FORWARD MOTION TO RETRACT YELLOW SAFETY COVER. TOOK OFF THE SAFETY BLADE TO REATTACH AND ATTEMPT AGAIN. RETRACTED YELLOW SAFETY MECHANISM AND THE BLADE SLIPPED OUT OF YELLOW SAFETY MECHANISM AND CUT SECOND FINGER/HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30158 XODUS REUSABLE SAFETY SCALPEL BLADE, SCALPEL - SURGICAL SCALPEL BLADES GES XODUS MEDICAL, INC. 90150 16AUG26

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other