BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S100 OPMI PICO

    MDR report key: 7688079 · Received July 13, 2018

    Report

    Report Number
    9615010-2018-00009
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 4, 2018
    Report Date
    June 13, 2018
    Manufacturer
    CARL ZEISS MEDITEC AG (CARL ZEISS MEDITEC AG (OBER
    Product Code
    HRM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE MANUFACTURER'S INVESTIGATION, IT WAS DISCOVERED THAT THE DEVICE HAD BEEN MODIFIED WITHOUT AUTHORIZATION FROM THE MANUFACTURER. THE S100 STAND (WHICH IS NORMALLY ATTACHED TO AN OPMI PICO HEAD) WAS FOUND ATTACHED TO THE HEAD FROM A DIFFERENT ZEISS MICROSCOPE - AN OPMI 1-FC. IN ADDITION, THE CASTORS ATTACHED TO THE BASE WERE FOUND TO BE NON-ZEISS SUPPLIED CASTORS. THE USER MANUAL FOR THE S100 CONTAINS CLEAR INSTRUCTIONS THAT ANY MODIFICATION OF THE SYSTEM IS FORBIDDEN. THE USER MANUAL ALSO STATES THAT ANY REPAIR WORK PERFORMED BY UNTRAINED AND/OR NON-CERTIFIED PERSON(S) IS PROHIBITED. ALSO, THE RECOMMENDED MAINTENANCE SCHEDULE FOR THIS DEVICE IS ANNUAL SERVICING; HOWEVER, NO SERVICE/MAINTENANCE RECORD FOR THIS DEVICE HAS BEEN FOUND BY THE MANUFACTURER. CARL ZEISS LTD. COMMUNICATED TO THE CUSTOMER TO TAKE THE MICROSCOPE OUT OF SERVICE.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT WHEN THE BRAKE WAS RELEASED ON THE S100 MICROSCOPE ARM, THE BALANCE FAILED AND THE MICROSCOPE HEAD FELL. IT WAS REPORTED BY THE CUSTOMER THAT THE PIVOT ON THE ARM'S PNEUMATIC SPRING HAD DISENGAGED FROM ITS MOUNT, AND HENCE WHEN THE BRAKE WAS ADJUSTED, THE MICROSCOPE HEAD FELL AND WAS CAUGHT BY THE USER. THE USER HAD TO CATCH THE HEAD TO AVOID HARM TO THE PATIENT. THE PNEUMATIC ARM IS HELD IN PLACE SOLELY BY TENSION AND IS NOT CAPTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527608 S100 OPMI PICO OPMI PICO HRM CARL ZEISS MEDITEC AG (CARL ZEISS MEDITEC AG (OBER S100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1