BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISTOOL

    MDR report key: 2132152 · Received June 13, 2011

    Report

    Report Number
    1831750-2011-05857
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY HAS STATED THAT DUE TO PATIENT CONFIDENTIALITY, THEY ARE UNABLE TO CONFIRM WHETHER PRIOR MEDICAL CONDITIONS EXISTED IN REGARD TO THE REPORTED NECK, HEAD AND BACK PAIN OR THE MEDICAL PROCEDURES CURRENTLY IN PROCESS. FURTHERMORE, IT HAS BEEN ADVISED THAT LITIGATION IS ANTICIPATED. A FOLLOW-UP REPORT SHALL BE SUBMITTED, SHOULD ANY FURTHER INFORMATION BE OBTAINED REGARDING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON WAS SITTING ON THE SURGISTOOL, REACHED BACK FOR SOMETHING BEHIND HIM, AND THE STOOL FIPPED OVER BACKWARDS. REPORTEDLY, THE SURGEON HIT HIS HEAD ON THE CABINET. SURGEON REPORTED NECK, HEAD AND BACK PAIN. MRI AND CTS OF NECK AND HEAD. RESULTS OF TESTS WERE NOT PROVIDED. DR HAS BEEN ON LEAVE FOR 3-4 WEEKS AND HAVING MEDICAL PROCEDURES. UNABLE TO CONFIRM IF MEDICAL PROCEDURES WERE RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGISTOOL STOOL, OPERATING-ROOM FZM STRYKER MEDICAL 0830 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other