BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, SURGICAL INSTRUMENT, DISPOSABLE

    MDR report key: 6109076 · Received November 17, 2016

    Report

    Report Number
    6109076
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    April 8, 2016
    Report Date
    October 24, 2016
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CYSTOSCOPY RESECTION OF BLADDER TUMOR THE CERAMIC TIP OF THE OUTER SHEATH (OBTURATOR) CAME OFF IN THE PATIENT'S URETHRA. THE SURGEON WAS ABLE TO REMOVE THE CERAMIC TIP WITH GRASPERS, NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759957 KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD VH202 1504

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR