BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANDELLA LASER

    MDR report key: 105064 · Received June 30, 1997

    Report

    Report Number
    105064
    Event Type
    Malfunction
    Date Received
    June 30, 1997
    Date of Event
    March 4, 1997
    Report Date
    March 13, 1997
    Manufacturer
    UNITED STATES MEDICAL CORP.
    Product Code
    LNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRESENTED TO SURGERY FOR CYSTO REMOVAL LT. JJ STENT URETEROSCOPIC CANDELA LASER LITHOTRIPSY W/VIDEO. ONCE THE CALCULUS WAS IDENTIFIED, A CANDELA LASER FIBER WAS PASSED THROUGH THE SCOPE & AN ATTEMPT MADE TO FRAGMENT THE STONE. THE LASER FAILED TO WORK & THE SURGEON WAS UNABLE TO FRAGMENT IT. THE STONE ENDED UP IN THE RENAL PELVIS. ANOTHER JJ URETERAL CATHETER WAS ADVANCED. SERVICE ENGINEER UNABLE TO REPAIR LASER. SERVICE ENGINEER FROM EQUIPMENT DEALER CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANDELLA LASER LASER LNK UNITED STATES MEDICAL CORP. LASER TRIPTER MDL 2000 7/87

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other