BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILIZABLE RUBBER CAP

    MDR report key: 1040328 · Received May 7, 2008

    Report

    Report Number
    MW5006779
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 7, 2008
    Manufacturer
    CARL ZEISS (OPHTHALMIC)
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLUE RUBBER KNOB COVER WAS USED TO COVER PUPILLARY DISTANCE ADJUSTMENT KNOB ON BINOCULAR TUBE. DURING PROCEDURE, KNOB COVER "POPPED OFF" THE ADJUSTMENT KNOB AND FELL ONTO THE STERILE FIELD OF THE MAYO STAND. CONTAMINATED FIELD BROKEN DOWN AND NEW SET-UP OBTAINED. PROCEDURE COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILIZABLE RUBBER CAP NONE EPT CARL ZEISS (OPHTHALMIC)

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention