BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50

    MDR report key: 17936394 · Received October 13, 2023

    Report

    Report Number
    9610617-2023-00290
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    October 20, 2021
    Report Date
    October 13, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCX
    UDI-DI
    04048551326657
    PMA / PMN Number
    K161554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS EVALUATED BY KST UNDER COMPLAINT (B)(4). PRODUCT ARRIVED AT KST ON (B)(6) 2022. UPON EVALUATION, PRODUCT WAS FOUND TO MEET ALL SPECIFICATIONS. THE ERROR LOG SHOWED THE MESSAGES OF THE CYLINDER EMPTYING AND SHUTTING OFF. THE VOLUME ON THE MACHINE WAS FOUND TO BE AT THE LOWEST LEVEL "1" DESPITE THE PRODUCT SHIPPING AT "4". THE IFU WAS FOUND TO HAVE NOTES ON KEEPING A SPARE DEVICE ON HAND AS WELL AS SYSTEMATIC ERROR MESSAGES. THE MOST PROBABLE ROOT CAUSE IS THAT THE ALARM WAS NOT RECOGNIZED BY THE CUSTOMER, BECAUSE THE AUDIO WAS TURNED DOWN TO THE LOWEST LEVEL "1". THE PREVIOUS REPORTABILITY DECISION FOR THIS EVENT WAS REVERSED BASED ON A RETROSPECTIVE REVIEW. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAVITY OF A PATIENT COLLAPSED DUE TO THE GAS FLOW STOPPED AFTER THE GAS BOTTLE NEEDED TO BE CHANGED. NO ALARM HAD BEEN ISSUED BY THE DEVICE TO PREVENT THE PROBLEM. NO NEGATIVE IMPACT TO THE PATIENT DUE TO THE LOSS OF PRESSURE IN THE CAVITY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683450 ENDOFLATOR 50 ENDOFLATOR FCX KARL STORZ SE & CO. KG UI500 04048551326657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown