BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50

    MDR report key: 17750272 · Received September 14, 2023

    Report

    Report Number
    9610617-2023-00238
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    June 29, 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
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 TOUCH SCREEN WAS ALSO FOUND TO HAVE INTERNAL DEBRIS SO IT WAS ALSO REPLACED. 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 STOPPED WORKING AND DISPLAYED ERROR MESSAGE DURING PEDIATRIC LAPAROSCOPIC SURGERY. THE OPERATOR FOLLOWED THE INSTRUCTION TO RESTART THE SYSTEM SEVERAL TIMES, WHICH DID NOT RESOLVE THE ISSUE. ANOTHER BACK-UP UNIT WAS UTILIZED TO COMPLETE THE SURGERY. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948645 ENDOFLATOR 50 ENDOFLATOR 50 FCX KARL STORZ SE & CO. KG UI500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown