BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD HIGHLIGHT LASER FIBER

    MDR report key: 32555 · Received February 8, 1996

    Report

    Report Number
    1018233-1996-00001
    Event Type
    Injury
    Date Received
    February 8, 1996
    Date of Event
    February 2, 1996
    Report Date
    February 6, 1996
    Manufacturer
    MICROQUARTZ MEDICAL, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THE FIBER BROKE OFF AND FELL INTO THE PT'S BLADDER. THE PREVIOUSLY PLACED CYSTOSCOPE WAS REMOVED AND REPLACED WITH A LARGER SCOPE. GRASPING FORCEPS WERE INSERTED THROUGH THE LARGER SCOPE AND THE BROKEN TIP WAS RETRIEVED FROM THE PT'S BLADDER WITHOUT ANY FURTHER COMPLICATIONS BEING REPORTED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S PRODUCT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD HIGHLIGHT LASER FIBER LASER FIBER GEX MICROQUARTZ MEDICAL, INC. 03JFL001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention