BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING C/F RESECTOSCOPE SHEATH

    MDR report key: 1122214 · Received June 5, 2008

    Report

    Report Number
    1122214
    Event Type
    Injury
    Date Received
    June 5, 2008
    Date of Event
    March 27, 2008
    Report Date
    June 5, 2008
    Manufacturer
    GYRUS ACMI, INC. - NORWALK
    Product Code
    FDC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008, AT 1300 HRS IN HOSP OR, A RESECTING SCOPE WAS USED DURING A CYSTOSCOPY LASER ABLATION OF THE PROSTATE SURGERY. THE INSTRUMENTS WERE SENT TO CENTRAL SVS TO BE CLEANED AND STERILIZED AND IT WAS NOTED THAT THE CERAMIC TIP OF THE SCOPE WAS MISSING. THE PHYSICIAN WAS NOTIFIED, AN X-RAY WAS ORDERED, WHICH REVEALED A RADIOPAQUE MOBILE OBJECT IN THE BLADDER CONSISTENT IN SIZE AND NATURE WITH THE MISSING CERAMIC PIECE. THE PT WAS RETURNED TO THE OR AND THE FOREIGN BODY WAS REMOVED FROM THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING C/F RESECTOSCOPE SHEATH ROTATING C/F RESECTOSCOPE SHEATH FDC GYRUS ACMI, INC. - NORWALK ERIS-CF25 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention