BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50

    MDR report key: 17751409 · Received September 14, 2023

    Report

    Report Number
    9610617-2023-00240
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    March 5, 2021
    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
    TX, 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 WAS 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 OUT OF BOX FAILURE. IT WAS THE FIRST TIME THE SYSTEM BEING PUT TO USE. THE SYSTEM DISPLAYED "SYSTEM ERROR PLEASE POWER CYCLE". SERVICE ENGINEER ATTEMPTED TO POWER CYCLE 8 TIMES AND THE ERROR MESSAGE PERSISTED. THE SYSTEM WAS ONLY TESTED FOR GENERAL POWER INSPECTION BY BIOMED. ANOTHER SYSTEM WAS USED TO TREAT THE PATIENT. THERE WAS NO REPORT OF IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302872 ENDOFLATOR 50 ENDOFLATOR 50 FCX KARL STORZ SE & CO. KG UI500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown