BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HGM

    MDR report key: 399687 · Received June 13, 2002

    Report

    Report Number
    1720381-2002-00003
    Event Type
    Injury
    Date Received
    June 13, 2002
    Date of Event
    May 22, 2002
    Report Date
    May 28, 2002
    Manufacturer
    LUMENIS (FORMER FISMA)
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A "PRP" MEDICAL PROCEDURE FOR ONE EYE. SEVERAL DAYS LATER PT REPORTED TO NURSE A VISION PROBLEM WITH THAT EYE. NURSE CHECKED PT'S VISION AND FOUND THAT IT WAS WORSE THAN PRIOR TO THE "PRP" PROCEDURE. FURTHER CHECKING REVEALED UNEXPECTED LASER BURN DAMAGE TO THE EYE. NURSES REPORTED THIS TO FACTORY REP DURING INTERVIEW ABOUT THE FOLLOWING INCIDENT. BIO-TECH AT THE HOSP REQUESTED A SERVICE CALL TO THEIR LOCATION TO CHECK A LASER AND SLIT LAMP SYSTEM THAT HAD BEEN USED IN A MEDICAL PROCEDURE WHERE A PT HAD BEEN INJURED. BIOTECH ALSO REPORTED THAT AN INTERN UNDER THE SUPERVISION OF ANOTHER DR FIRED LASER THROUGH THE SLIT LAMP INTO THE WRONG PART OF THE PT'S EYE. THIS ACTION CAUSED THE INJURY STATED IN THE PRECEDING PARAGRAPH. BIOTECH ALSO COMMENTED THAT IT WAS REPORTED THAT THE PT WAS MOVING AROUND DURING THE PROCEDURE AND THAT MAY HAVE CONTRIBUTED TO THE ERROR. BIO-TECH STATED THAT THEY FELT THE LASER AND SLIT LAMP SYSTEM OPERATED NORMALLY BUT AS PART OF THE HOSP INTERNAL INVESTIGATION THE SYSTEM SHOULD BE CHECKED BY A FACTORY SEVICE TECH. BIOTECH DISABLED THE LASER SO THAT IT COULD NOT BE USED PENDING FACTORY SERVICE CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM MEDICAL LASER GEX LUMENIS (FORMER FISMA) E50-3-K05-2-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SLIT LAMP HGM S12-A-K05-1-00.