BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50

    MDR report key: 17802387 · Received September 22, 2023

    Report

    Report Number
    9610617-2023-00244
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Report Date
    September 22, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCX
    PMA / PMN Number
    K161554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUS REPORTABILITY DECISION FOR THIS EVENT WAS REVERSED BASED ON A RETROSPECTIVE REVIEW. THE REPORTED DEVICE WAS RETURNED AND EVALUATION WAS PERFORMED. THE REPORTED COMPLAINT WAS CONFIRMED. NEW FLOW SENSORS, SENSOR INTERFACE II, CONNECTOR UPGRADE AND FILTER BOARD WERE REPLACED. THE REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ENDOFLATOR 50 SYSTEM FAILED DURING AN OVERNIGHT LAPAROSCOPIC PROCEDURE. THE ENGINEER PERFORMED MULTIPLE TESTS AND THE SYSTEM STILL GIVES ERROR 321, "SENSOR DEVIATION". THE SYSTEM WAS IN GOOD CONDITION PRIOR TO THE PROCEDURE. TO COMPLETE THE PROCEDURE, THE SURGEON USED ANOTHER INSUFFLATOR. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834652 ENDOFLATOR 50 ENDOFLATOR 50 FCX KARL STORZ SE & CO. KG UI500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown