BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD UROLASE RIGHT ANGLE LASER FIBER

    MDR report key: 1515 · Received October 5, 1992

    Report

    Report Number
    1018233-1992-00001
    Event Type
    Injury
    Date Received
    October 5, 1992
    Date of Event
    September 16, 1992
    Report Date
    September 25, 1992
    Manufacturer
    TRIMEDYNE, INC.
    Product Code
    LWX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LASING PROCEDURE, THE FIBER TIP BURNED OUT AND SEPERATED FROM THE FIBER SHAFT. BIOSPY FORCEPS WERE INSERTED THROUGH THE PREVIOUSLY PLACED SCOPE AND THE TIP WAS RETRIEVED AS DESCRIBED IN THE PRODUCT LABELING. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTEDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD UROLASE RIGHT ANGLE LASER FIBER LASER FIBER LWX TRIMEDYNE, INC. UNKNOWN 7231

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention