BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 507229 · Received January 2, 2004

    Report

    Report Number
    MW1030784
    Event Type
    Injury
    Date Received
    January 2, 2004
    Date of Event
    December 18, 2003
    Report Date
    December 31, 2003
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAVING LASER PROSTATE WITH MINI TURP FOR PROSTATIC HYPERTROPHY WITH OBSTRUCTION. AT THE END OF THE PROCEDURE WHILE EVACUATING CHIPS IT WAS NOTED PLASTIC MATERIAL AT THE BLADDER FLOOR DETERMINED TO BE THE INSULATING SHEATH FROM THE TIP OF THE RESECTOSCOPE. ATTEMPTED RECOVERY WITH USE OF LITHOTRITE, 18 FR. UROMAX URETERAL DILATOR AND 3 PRONG GRASPER OF PERCUTANEOUS NEPHROSCOPY INSTRUMENT ALL FAILED. DETERMINED AFTER CONSULTATION WITH ANOTHER SURGEON, TO TERMINATE PROCEDURE DUE TO LENGTH OF OPERATIVE AND ANESTHESIA TIME AND PT'S GENERAL MEDICAL CONDITION. PLAN SURGERY IN 4 WEEKS WITH SUPRAPUBIC APPROACH FOR REMOVAL FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RESECTOSCOPE SHEATH FR #28 FED OLYMPUS AMERICA, INC. A 2641 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention