BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOFLATOR 50

    MDR report key: 18466543 · Received January 8, 2024

    Report

    Report Number
    2020550-2024-00004
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 8, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCX
    UDI-DI
    04048551326657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LH
    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. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN "ERROR 3FD: POWER ON TEST ERROR. LAPAROTOMY INSTEAD OF LAPAROSCOPY." SINCE THE DESCRIPTION INDICATES THAT A LAPAROTOMY HAD TO BE PERFORMED INSTEAD OF A LAPAROSCOPY, THIS EVENT HAS BEEN EVALUATED AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601062 ENDOFLATOR 50 LAPAROSCOPIC INSUFFLATOR FCX KARL STORZ SE & CO. KG UI500 04048551326657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other