BEUDAMED
    FDA Adverse Event Summary report: N

    OES PRO ROTATABLE RESECTOSCOPE

    MDR report key: 3736548 · Received April 4, 2014

    Report

    Report Number
    MW5035536
    Date Received
    April 4, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 3, 2014
    Manufacturer
    OLYMPUS
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ENDOSCOPIC TREATMENT OF PROSTATIC BLADDER, STATUS POST TRANSURETHRAL RESECTION. SURGEON EXPERIENCED SCOPE FAILURE AS THE TIP PORTION OF THE SCOPE BROKE OFF AND FELL INTO BLADDER AND WAS UNABLE TO RETRIEVE IN THE COURSE OF ATTENDING TO THE PT'S HEMORRHAGING AND CONDITION. PIECE LEFT IN UNTIL PT MORE STABLE AND PT TAKEN TO RECOVERY ROOM. IN RECOVERY ROOM, PT BECAME UNSTABLE AND RETURNED TO SURGERY WHERE SURGEON PERFORMED OPEN CYSTOTOMY FOR CLOT EVACUATION, FOREIGN BODY REMOVAL AND OVER-SEWING OF INTRA PROSTATIC BLEEDING. DATES OF USE: APPROX 4 YEARS. DIAGNOSIS OR REASON FOR USE: ENDOSCOPY CYSTOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205486 OES PRO ROTATABLE RESECTOSCOPE OES PRO FJL OLYMPUS A22040A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization