BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50

    MDR report key: 17741340 · Received September 13, 2023

    Report

    Report Number
    9610617-2023-00237
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    December 15, 2020
    Report Date
    September 13, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCX
    PMA / PMN Number
    K161554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 BOARDS WERE REPLACED. THE REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. THE EVENT IS FILED UNDER INTERNAL (B)(6) COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ENDOFLATOR 50 STOPPED WORKING AND GAVE AN ERROR DURING LAP CHOLE SURGERY. PER REPORT, THE SYSTEM GAVE THE ERROR "3FF: POWER ON TEST ERROR - A SYSTEM FAILURE OCCURRED. YOU HAVE LIMITED ACCESS TO THE SETTINGS MENU ONLY, RESTART THE DEVICE IN ORDER TO PROCEED, CONTACT (B)(6) IF PROBLEM PERSISTS". THE SURGEON USED A BACK-UP UNIT TO COMPLETE THE SURGERY. THE DEVICE WAS REPORTED TO BE IN EXCELLENT CONDITION PRIOR TO USE. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589897 ENDOFLATOR 50 ENDOFLATOR 50 FCX KARL STORZ SE & CO. KG UI500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown