BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50, W/INTEGRATED SCB MODULE

    MDR report key: 15121876 · Received July 28, 2022

    Report

    Report Number
    9610617-2022-00132
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    July 1, 2022
    Report Date
    November 23, 2022
    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
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. ACCORDING TO THE TREND REVIEW, ONE PREVIOUS CASE CAUSED A SERIOUS INJURY. THUS, A REPORT IS REQUIRED.

    Additional Manufacturer Narrative · 0

    AS PER THE MANUFACTURER'S INVESTIGATION REPORT: THE PRODUCT INSPECTION CANNOT BE PERFORMED AT KST BECAUSE THE DEVICE HAS BEEN LOST INTERNALLY. BASED ON THE INVESTIGATION RESULTS OF THE US COLLEAGUES, THE DEVICE FAILED DURING THE LONG-TERM TEST. THE MOST PROBABLE ROOT CAUSE IS A FAULT WITH THE POWER SUPPLY. THIS COULD BE A PROBLEM WITH THE POWER INPUT SOCKET OR THE FUSE, AMONG OTHER THINGS. IF THE DEVICE COULD BE FOUND, THE REPORT WILL BE RE-OPENED AND ADJUSTED ACCORDINGLY. A WARNING IN THE IFU IS LISTED TO ALWAYS KEEP A REPLACEMENT DEVICE ON HAND IN CASE THE DEVICE SHOULD FAIL.

    Additional Manufacturer Narrative · 0

    DURING INITIAL TESTING, THE UNIT POWERED OFF; IT IS WORKING INTERMITTENTLY. THE UNIT WILL BE SENT TO THE FACTORY IN GERMANY FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE ENDOFLATOR 50 UNIT STOPPED PUSHING GAS DURING A CASE. THEY BROUGHT IN A BACK-UP UNIT TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286208 ENDOFLATOR 50, W/INTEGRATED SCB MODULE LAPAROSCOPIC GAS DISTENSION SYSTEM FCX KARL STORZ SE & CO. KG UI500 04048551326657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other