BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI PICO WITH S100 FLOOR STAND

    MDR report key: 3042987 · Received March 7, 2013

    Report

    Report Number
    9615010-2013-00005
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER INSPECTED THE S100 FLOOR STAND AND DETERMINED THAT THE BRACKET THAT SECURES ONE END OF THE TILTING ARM'S PNEUMATIC SPRING WAS BENT OUTWARDS ON BOTH SIDES TO THE EXTENT THAT THE SPRING WAS NO LONGER ENGAGED. THE FIELD SERVICE ENGINEER REPLACED THE BRACKET AND PNEUMATIC SPRING. IT IS PROBABLE THAT THE BRACKET WAS TAMPERED WITH BECAUSE, BY DESIGN, IT IS NOT SUBJECT TO LATERAL FORCES. WITHOUT A FUNCTIONAL PNEUMATIC SPRING, THE S100 TILTING ARM AND ATTACHED MICROSCOPE WILL ROTATE DOWNWARDS UNDER THE FORCE OF GRAVITY WHEN IT IS UNLOCKED. THE MICROSCOPE, WHICH WAS MANUFACTURED IN 09/2002, HAS NEVER BEEN SERVICED BY THE MANUFACTURER. SITE CONTACT INFORMATION: (B)(6), DDS ENDODONTIST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS STRUCK ON THE CHEEK BONE BY THE MICROSCOPE HEAD DURING AN ENDODONTIC SURGICAL PROCEDURE (ROOT CANAL) PERFORMED WITH AN OPMI PICO MICROSCOPE MOUNTED ON AN S100 FLOOR STAND. THE INCIDENT OCCURRED WHEN THE HEALTHCARE PROFESSIONAL RELEASED THE TILTING ARM LOCK ON THE S100 FLOOR STAND. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SOME REDNESS AND SWELLING BUT DID NOT REQUIRE MEDICAL INTERVENTION AND THAT THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT THE USE OF THE MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98387 OPMI PICO WITH S100 FLOOR STAND MICROSCOPE, SURGICAL, GENERAL & PLASTIC EPT CARL ZEISS MEDITEC AG S100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR