BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSTIC 360 DIFFUSER

    MDR report key: 413390 · Received August 26, 2002

    Report

    Report Number
    MW1025976
    Event Type
    Malfunction
    Date Received
    August 26, 2002
    Date of Event
    July 30, 2002
    Report Date
    August 19, 2002
    Manufacturer
    RARE EARTH MEDICAL INC
    Product Code
    LQJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS BEING TREATED WITH PHOTODYNAMIC THERAPY (PDT) FOR ESOPHAGEAL CANCER. TWO SEPARATE DEVICES (CALLED THE "LIGHTSTIC 360 DIFFUSER") WERE BEING USED IN THE PROCEDURE, BOTH OF THEM MADE BY CARDIOFOCUS, INC. ACCORDING TO MFR'S LITERATURE, "THIS SINGLE-USE-ONLY FIBEROPTIC DEVICE IS INTENDED TO DELIVER LASER ENERGY TO DESIRED TISSUE. DELIVERY OF THE LIGHT IS INTENDED TO PHOTOACTIVATE A DRUG CONTAINED IN THE TARGETED TISSUE AS PART OF A PRE-CLINICAL PHOTODYNAMIC THERAPY PROCEDURE." THE TIPS (ON THE SHAFT PORTION) OF BOTH DIFFUSERS BROKE OFF DURING THE ENDOSCOPIC PROCEDURE. THE TIPS THAT BROKE OFF OF THE PRIMARY DEVICES WERE RETRIEVED DURING OR IMMEDIATELY FOLLOWING THE SURGERY AND WERE DISCARDED. THE REMAINING PORTIONS OF BOTH DEVICES ARE BEING STORED IN THE RISK MGMT DEPT. BY LOOKING AT THE REMAINING PORTIONS OF THE TWO DEVICES, THE POINT WHERE THE BREAKAGE OCCURRED ON THE SHAFT OF EACH DEVICE APPEARS BLACKENED, AS IF BURNT. THE POINTS OF BREAKAGE ON THE TWO DIFFUSERS HAVE THE APPEARANCE OF A BLACKENED MATCHSTICK TIP THAT HAD ONCE BEEN LIGHTED. NO COMPLICATIONS RESULTED FROM THIS EVENT, THE SURGERY WAS NOT EXTENDED IN ANY WAY AND ALL DEVICE FRAGMENTS WERE RETRIEVED. UNFORTUNATELY, THE BROKEN-OFF TIPS, ONCE RETRIEVED, WERE DISCARDED DURING OR IMMEDIATELY FOLLOWING THE SURGERY; HOWEVER, THE REMAINING PORTION OF EACH OF THE TWO DIFFUSERS WAS PRESERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSTIC 360 DIFFUSER PHOTODYNAMIC THERAPY DIFFUSER LQJ RARE EARTH MEDICAL INC UNK UNK
    2 LIGHTSTIC 360 DIFFUSER PHOTODYNAMIC THERAPY DIFFUSER LQJ RARE EARTH MEDICAL INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR