BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROSCOPE ONLY FOR MIP L

    MDR report key: 19175981 · Received April 24, 2024

    Report

    Report Number
    2020550-2024-00116
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 24, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FGA
    UDI-DI
    04048551366660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OBJECTIVE LENS COME OUT FROM TIP DURING A PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ON (B)(6) 2024 WE GOT NEW INFORMATION, THAT DURING PROCEDURE THE LENS FALL OUT INSIDE PATIENT BODY AND CAUSED A PROLONGATION FOR MORE THAN 60 MINUTES. IT IS UNCLEAR IF THE SEPARATED PART COULD BE RETRIEVED. THEREFORE, AS A PRECAUTION, THE CASE IS DEEMED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515385 NEPHROSCOPE ONLY FOR MIP L NEPHROSCOPE FGA KARL STORZ SE & CO. KG 27840KA 1003RC 04048551366660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other