BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50

    MDR report key: 17750503 · Received September 14, 2023

    Report

    Report Number
    9610617-2023-00239
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 27, 2020
    Report Date
    September 14, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCX
    PMA / PMN Number
    K161554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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. THE EVALUATOR FOUND THE PRESSURE SENSOR BOARD AND THE FILTER BOARD BOARDS WERE DEFECTIVE. 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 EXPERIENCED ISSUE AND DISPLAYED ERROR MESSAGES DURING LAPAROSCOPIC CHOLECYSTECTOMY SURGERY. THE SYSTEM DISPLAYED SYSTEM FAILURE MESSAGE AND NO GAS WARNING ON MONITOR WITH LIMITED ACCESS. THE ENGINEER HAD TO RESTART THE SYSTEM 6 OR 7 TIMES UNTIL THE SYSTEM STOPPED WORKING. ANOTHER SYSTEM WITH STRYKER INSUFFLATOR ON IT TO COMPLETE THE SURGERY. THERE WAS NO REPORT OF INJURY TO THE PATIENT; HOWEVER, THE SURGEON WAS LOSING INSUFFLATION WHICH TOOK THE SURGERY MUCH LONGER THAN IT SHOULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314934 ENDOFLATOR 50 ENDOFLATOR 50 FCX KARL STORZ SE & CO. KG UI500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown