BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTREE CEILING MOUNT MICROSCOPE SYSTEM

    MDR report key: 450049 · Received March 19, 2003

    Report

    Report Number
    1937051-2003-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2003
    Date of Event
    February 21, 2003
    Report Date
    March 18, 2003
    Manufacturer
    GLOBAL SURGICAL CORP.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003, GLOBAL RECEIVED ACALL FROM ONE OF THE FIELD REPRESENTATIVES ADVISING THAT MICROSCOPE ARM HAD STRUCK A PATIENT IN THE LIP WHEN A GAS SPRING, A COMPONENT OF THE ARM SUPPORT SYSTEM, EXPERIENCED A SUDDEN FAILURE. THE EVENT ACTUALLY OCCURRED ON DECEMBER, 2002, BUT WAS NOT REPORTED UNTIL FEBRUARY. THE INJURY TO THE PATIENT WAS REPORTED TO BE OF A MINOR NATURE REQUIRING ONLY MINOR MEDICAL TREATMENT. GLOBAL SENT THE ARM ASSEMBLY AND REQUESTED THE FAILED UNIT BE RETURNED FOR EVALUATION. IN MARCH GLOBAL RECEIVED THE FAILED ARM ASSEMBLY. UPON EXAMINATION, CONFIRMED THAT THE PRESSURIZED GAS SPRING HAD LOST A SIGNIFICANT AMOUNT OF PRESSURE BUT DID NOT EXHIBIT EVIDENCE THAT THE FAILURE WAS SUDDEN AND CATASTROPHIC AS DESCRIBED. IN RECONSTRUCTING THIS FAILURE AND BASED ON PAST EXPERIENCE, THE GAS SPRINGS HAVE BEEN KNOWN TO EXHIBT A GRADUAL LOSS OF PRESSURE OVER TIME. AS THIS OCCURS, THE USERS ATTEMPT TO COMPENSATE FOR THE LOSS OF SPRING PRESSURE BY INCORRECTLY TIGHTENING A FRICTION BRAKE. THE FRICTION BRAKE WAS NOT DESIGNED TO PERFORM IN THIS MANNER AND OVER TIME CAN LOSE ITS BRAKING CAPACITY ALLOWING THE ARM TO DROP DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTREE CEILING MOUNT MICROSCOPE SYSTEM DENTAL MICROSCOPE EPT GLOBAL SURGICAL CORP. M 704 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA