BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50

    MDR report key: 18066711 · Received November 3, 2023

    Report

    Report Number
    9610617-2023-00348
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    September 28, 2023
    Report Date
    January 29, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCX
    UDI-DI
    04048551326657
    PMA / PMN Number
    K161554
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED ON 2023-10-25. THE INVESTIGATION OF THE PRODUCT WAS COMPLETED ON 2024-01-19. THE PROBLEM DESCRIBED BY THE CUSTOMER CANNOT BE REPRODUCED. THE HIGH VOLTAGE AND ELECTRICAL SAFETY TEST SHOWED THAT THE ELECTRIC SHOCK WAS NOT CAUSED BY THE INSUFFLATOR (UI500). THE DEVICE HAS BEEN FULLY TESTED AND WORKS PERFECTLY. THE OVERVOLTAGE MUST HAVE ANOTHER CAUSE, WHICH CANNOT BE VERIFIED BY INSPECTING THE ENDOFLATOR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID:(B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTION B5. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT HAPPENED DURING THE INSTALLATION OF THE INSUFFLATOR. IN THE MOMENT TO CONNECT THE INSUFFLATOR FILTER 031122-01 THE EQUIPMENT GAVE AN ELECTRIC SHOCK TO THE OPERATING ROOM ASSISTANT.

    Description of Event or Problem · 0

    ON FRIDAY (B)(6) 2023 THE DELEGATE OF THE AREA CAME IN PERSON TO THE HOSPITAL TO KNOW MORE AND THE SUPERVISOR TOLD HIM THAT THE ASSISTANT IS ON MEDICAL LEAVE SINCE HE SAYS THAT HE HAS NO STRENGTH IN THE ARM, PARESTHESIA AND SWOLLEN HAND. ON MONDAY (B)(6) 2023 THE DELEGATE SAW THE CHIEF OF SURGERY SERVICE AND TOLD HER THAT SHE HAD SPOKEN WITH THE ASSISTANT AND REMAINED THE SAME. THEY HAD TO DO MEDICAL TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952891 ENDOFLATOR 50 LAPAROSCOPIC INSUFFLATOR FCX KARL STORZ SE & CO. KG UI500 WO10857 04048551326657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other