BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPMI PICO S100 WALL MOUNT, LONG ARM

    MDR report key: 2163649 · Received June 10, 2011

    Report

    Report Number
    9615010-2011-00006
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CARL ZEISS SURGICAL GMBH
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BEFORE THE INSTALLATION, IT IS THE CUSTOMER'S RESPONSIBILITY TO ENSURE THAT THE WALL AT THE SITE OF THE INSTALLATION IS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS AND SPECIFICATIONS PROVIDED IN THE PLANNING MANUAL. THE CUSTOMER FIRST INSTALLS THE WALL PLATE ON THE WALL FOR THE S100 WALL MOUNT. THEN THE S100 WALL FLANGE (MOUNTING BRACKET) IS MOUNTED ON THE WALL PLATE AND HELD TOGETHER BY 3 BOLTS AND 3 METAL WASHERS. THEN THE WALL MOUNT IS MOUNTED ON THE WALL FLANGE AND THE MICROSCOPE IS SUSPENDED FROM THE ARM OF THE WALL MOUNT. IT WAS DETERMINED THAT IN THIS CASE, THE METAL WASHERS BROKE IN THE AREA WHERE THE THREADED PART JOINS THE FLAT SURFACE. AS THE WASHERS WERE HOLDING THE WALL PLATE AND FLANGE TOGETHER, THEIR BREAKAGE CAUSED THE WALL FLANGE TO COLLAPSE ALONG WITH THE WALL MOUNT AND MICROSCOPE. THE OFFICE COULD NOT CONFIRM IF THE MOVING AND INSTALLATION COMPANY FOLLOWED THE PROPER INSTALLATION PROCEDURES OR IF THE SCREWS WERE TORQUED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    AN OPMI PICO MICROSCOPE SUSPENDED FROM AN S100 WALL MOUNT AT THE CUSTOMER'S OFFICE BECAME LOOSE FROM THE MOUNTING BOARD AND FELL WHILE AN ADULT MALE WAS BEING EXAMINED. A PORTION OF THE FALLING ASSEMBLY GRAZED THE PATIENT WHICH CAUSED REDNESS OF THE SKIN, BUT NO SWELLING. NO MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER PURCHASED THE UNIT IN (B)(6) 2006. THE WALL MOUNT WAS ORIGINALLY INSTALLED AT THE CUSTOMER'S LOCATION AT THAT TIME, HOWEVER, IT WAS SUBSEQUENTLY RELOCATED INTO A DIFFERENT ROOM. THE EQUIPMENT WAS MOVED BY A MOVING AND INSTALLATION COMPANY WHICH IS NOT ASSOCIATED WITH CARL ZEISS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI PICO S100 WALL MOUNT, LONG ARM WALL MOUNT FOR ENT DIAGNOSTIC MICROSCOPE EPT CARL ZEISS SURGICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other