BEUDAMED
    FDA Adverse Event Other Summary report: N

    STORZ RESECTOSCOPE SHEATH

    MDR report key: 442420 · Received February 5, 2003

    Report

    Report Number
    442420
    Event Type
    Other
    Date Received
    February 5, 2003
    Date of Event
    November 5, 2002
    Report Date
    December 16, 2002
    Manufacturer
    KARL STORZ, ENDOSCOPY-AMERICA INC
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD WAS IN THE PROCESS OF USING THE RESECTOSCOPE WHEN THE TIP SHATTERED AND CAME OFF IN THE PT'S UTERUS. PIECES OF THE TIP WERE RETRIEVED, BUT THERE WAS NO WAY TO VERIFY IF ALL OF THE PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ RESECTOSCOPE SHEATH RESECTOSCOPE SHEATH FED KARL STORZ, ENDOSCOPY-AMERICA INC 27040XA/XC/26040XA *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR