BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGISTOOL

    MDR report key: 3866057 · Received June 11, 2014

    Report

    Report Number
    0001831750-2014-03059
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 18, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED CONDITION OF THE STOOL TIPPING IS LIKELY USER ERROR. HOWEVER, THIS COULD NOT BE CONFIRMED AS THE UNIT WAS NOT MADE AVAILABLE TO STRYKER FOR EVALUATION. A LIKELY CAUSE TO THE EVENT IS DUE TO THE CUSTOMER LEANING TOO FAR BACK WHILE PUSHING THE STOOL BACKWARDS, CAUSING A TIP. THE DEVICE WAS NOT MADE AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN INCIDENT OF A PERSONNEL TIPPING OVER BACKWARDS OFF THE SURGISTOOL WHEN PUSHING AWAY FROM PATIENT. NO PARTS ON THE STOOL WAS NOTED TO HAVE FAILED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN INCIDENT OF A PERSONNEL TIPPING OVER BACKWARDS OFF THE SURGISTOOL WHEN PUSHING AWAY FROM PATIENT. NO PARTS ON THE STOOL WAS NOTED TO HAVE FAILED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344082 SURGISTOOL STOOL, OPERATING-ROOM FZM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1