BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDO KIT

    MDR report key: 77258 · Received March 14, 1997

    Report

    Report Number
    77258
    Event Type
    Other
    Date Received
    March 14, 1997
    Date of Event
    January 23, 1997
    Report Date
    March 14, 1997
    Manufacturer
    COHERANT MEDICAL LASER GRP.
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING RETINA SURGERY, THE SHUTTER ON THE EYE SAFETY FILTER MALFUNCTIONED AND WOULD NOT REOPEN. THIS CAUSED THE PROCEDURE TO BE COMPLETED WITH THE LASER BEING USED ON THE OUTSIDE OF THE EYE. THERE WAS MORE BLEEDING THAN WOULD HAVE BEEN IF THE LASER HAD PERFORMED PROPERLY. THIS WAS NOT THE SURGEON'S BEST OPTION BUT THE OUTCOME WAS THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO KIT ENDO KIT HQF COHERANT MEDICAL LASER GRP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other