BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI PROERGO WITH S7 FLOOR STAND

    MDR report key: 3130287 · Received May 22, 2013

    Report

    Report Number
    9615010-2013-00013
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE REPRESENTATIVE (FSE) PERFORMED AN ON-SITE INSPECTION OF THE OPMI PROERGO SURGICAL MICROSCOPE SYSTEM. HE RE-SECURED THE BINOCULAR TUBE AND EYE PIECES, ONTO THE MICROSCOPE HEAD AND REBALANCED THE SYSTEM. ALL FUNCTIONS AND CONTROLS WERE FOUND TO BE OPERATING PROPERLY. THE FSE ALSO PROVIDED THE CLINICAL ASSISTANT PROFESSOR AND CLINICAL ASSOCIATE PROFESSOR WITH A DEMONSTRATION OF THE OPERATION OF ALL FUNCTIONS AND CONTROLS. THE USER MANUAL INSTRUCTS THE USER TO PERFORM THE FOLLOWING SAFETY MEASURES BEFORE EVERY USE: "TO PREVENT ACCESSORIES FROM FALLING DOWN, CHECK BEFORE EVERY USE THAT ACCESSORIES ARE SECURELY LOCKED IN POSITION AND SECURING SCREWS ARE FIRMLY TIGHTENED." SITE CONTACT INFORMATION: DR (B)(6), CLINICAL ASSISTANT PROFESSOR; (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASSEMBLY, CONSISTING OF THE BINOCULAR TUBE AND EYE PIECES, FELL OFF WHILE POSITIONING AN OPMI PROERGO SURGICAL MICROSCOPE FOR A ROOT CANAL PROCEDURE. THE FALLING ASSEMBLY CONTACTED THE PATIENT'S SHOULDER AND LANDED IN THE HEALTHCARE PROVIDER'S LAP. NEITHER THE PATIENT, NOR THE HEALTHCARE PROVIDER REQUIRED MEDICAL ATTENTION. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT, USING A REPLACEMENT MICROSCOPE, AFTER AN APPROXIMATELY 8-10 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226356 OPMI PROERGO WITH S7 FLOOR STAND MICROSCOPE, SURGICAL, GENERAL AND PLASTIC EPT CARL ZEISS MEDITEC AG PROERGO NA

    Patients

    Seq Age Sex Outcome Treatment
    1