BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 21655103 · Received March 20, 2025

    Report

    Report Number
    2020550-2025-00340
    Event Type
    Death
    Date Received
    March 20, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 20, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APART FROM THE INFORMATION THAT THE PROCEDURE WAS A "HOLEP CASE" THERE IS NO FURTHER INFORMATION AVAILABLE. THEREFORE, IT COULD NOT BE DETERMINED WHICH PRODUCT WAS INVOLVED IN THIS EVENT. THE PRODUCT CODE "GEX" STATED IN SECTION D2 WAS DETERMINED AS THE MOST FITTING BASED ON THE LIMITED INFORMATION. THE PRODUCT CODE MAY CHANGE IF FURTHER INFORMATION BECOMES AVAILABLE. THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION IT WAS REPORTED THAT A PATIENT PASSED AWAY AFTER A HOLEP CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451596 UNKNOWN UNKNOWN GEX KARL STORZ SE & CO. KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death