BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V. MUELLER

    MDR report key: 835589 · Received February 21, 2007

    Report

    Report Number
    835589
    Event Type
    Malfunction
    Date Received
    February 21, 2007
    Date of Event
    November 24, 2006
    Report Date
    February 21, 2007
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES
    Product Code
    FDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    MALE PT UNDERWENT CYSTOSCOPY, TRANSURETHRAL RESECTION OF BLADDER TUMOR FOR GROSS HEMATURIA AND BLADDER OUTLET OBSTRUCTION. DURING THE PROCEDURE, A LOOP WAS USED. TISSUE ADHERED TO THE LOOP. THE LOOP WAS REMOVED FROM PATIENT TO CLEAN. WHEN LOOP RE-INTRODUCED TO PATIENT, LOOP APPEARED TO BE GONE. UPON RE-EXAMINATION OF THE BLADDER, LOOP LOCATED AND REMOVED. LOOP AND HANDLE AVAILABLE IN OR DEPARTMENT. TO BE RETURNED TO MANUFACTURER FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V. MUELLER ESU LOOP ELECTRODE, RESECTOSCOPE FDC CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES * AVEED02

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR NO OTHER THERAPIES