BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 20452736 · Received October 15, 2024

    Report

    Report Number
    2020550-2024-00381
    Event Type
    Injury
    Date Received
    October 15, 2024
    Report Date
    October 15, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    JYQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT A NEEDLE-LIKE STRUCTURE APPROXIMATELY 30MM LONG WAS FOUND IN A PATIENTS BLADDER. THE SURGEON INFORMED THAT THIS PATIENT HAD UNDERGONE A TURP PROCEDURE APPROXIMATELY 2 YEARS AGO AND THAT THIS NEEDLE LIKE STRUCTURE MAY BE APART FROM A KARL STORZ SINGLE USE LOOP THAT WAS USED AT THAT TIME. THE ITEM NUMBER IS UNKNOWN AND IT IS UNCERTAIN IF THE "NEEDLE LIKE STRUCTURE" IS A KARL STORZ PRODUCT. NEVERTHELESS, AS A PRECAUTIONARY MEASURE A REPORT IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37843 UNKNOWN UNKNOWN JYQ KARL STORZ SE & CO. KG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other