BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIS

    MDR report key: 6312886 · Received February 8, 2017

    Report

    Report Number
    0002031963-2017-00002
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 5, 2017
    Report Date
    February 8, 2017
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE STAFF WAS ALLEGEDLY INJURED AS A RESULT OF THE EQUIPMENT BOOM NOT ARTICULATING UP/DOWN. AFTER FURTHER INVESTIGATION, IT WAS REPORTED THAT THE USER ATTEMPTED TO MANUALLY REPOSITION THE BOOM VERTICALLY, ALLEGEDLY RESULTING IN TWO PULLED MUSCLES. ADDITIONAL INFORMATION ON THE REPORTED PULLED MUSCLES WAS REQUESTED AND NOT YET RECEIVED. THE CUSTOMER REMOVED THE BOOM FROM SERVICE. A STRYKER FIELD SERVICE TECHNICIAN WENT ONSITE TO REPLACE THE MOTOR AND RETURN THE UNIT TO FULL USE. THE STRYKER FLEXIS OPERATING MANUAL (P13742 REV. R) OUTLINES IN SECTION 9.1.2 ADJUSTING VERTICAL POSITION ¿ ¿TO ADJUST THE HEIGHT OF AN ARTICULATING BOOM, PRESS AND HOLD THE UP BUTTON TO RAISE THE FLEXIS SYSTEM, PRESS THE DOWN BUTTON TO LOWER IT, AND RELEASE THE BUTTON TO STOP MOVEMENT.¿ ATTEMPTING TO MOVE THE BOOM WITHOUT THE BUTTONS FUNCTIONING WOULD BE CONSIDERED USE ERROR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STAFF WAS ALLEGEDLY INJURED AS A RESULT OF THE EQUIPMENT BOOM NOT ARTICULATING UP/DOWN. AS THIS OCCURRED PRIOR TO A CASE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95574 FLEXIS BOOM FQO STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other