BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50, W/INTEGRATED SCB MODULE

    MDR report key: 15031342 · Received July 15, 2022

    Report

    Report Number
    9610617-2022-00122
    Event Type
    Malfunction
    Date Received
    July 15, 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 CONFIRMED A PRESSURE SENSOR INTERRUPTION ERROR OCCURRED. ACCORDING TO THE TREND REVIEW, ONE PREVIOUS CASE CAUSED A SERIOUS INJURY. THUS, A REPORT IS REQUIRED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AGAIN FOR EVALUATION, AS IT SUBSEQUENTLY SHUT OFFF DURING A CASE (REF. MDR 9610617-2022-00132) AND, PER OUR US INSPECTION TEAM, THE UNIT POWERED OFF DURING ENDURANCE TEST. THE UNIT WAS FORWARDED TO THE MANUFACTURER IN GERMANY FOR FURTHER INVESTIGATION. 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.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE ENDOFLATOR 50 UNIT STOPPED PUSHING GAS IS TWO SEPARATE CASES. THERE WAS NO HARM TO THE PATIENT. THE DATE OF THE EVENTS COULD NOT BE CONFIRMED. THIS REPORT REPRESENTS CASE 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756352 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