BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOFLATOR 50

    MDR report key: 18466539 · Received January 8, 2024

    Report

    Report Number
    9610617-2024-00004
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    December 21, 2023
    Report Date
    May 22, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCX
    UDI-DI
    04048551326657
    PMA / PMN Number
    K161554
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION OF THE RETURNED DEVICE THE POWER ON ERROR 3FD COULD BE CONFIRMED. THE DEEPER INVESTIGATION HAS SHOWN THAT THE ERROR OCCURRED DUE TO A TOO HIGH LEAKAGE AT THE PROPORTIONAL VALVE DURING THE POWERON TEST. THE ERROR WAS MEASURABLE AND VISIBLE IN THE LOG-FILE. DURING THE TEST BY THE VERIFICATION ENGINEER THE FAULT WAS RESOLVED BY REPLACING IT WITH A NEW ONE OR BY DISASSEMBLING AND REASSEMBLING THE ORIGINAL PROPORTIONAL VALVE. IT IS CONCLUDED THAT THE PROPORTIONAL VALVE BROKE DUE TO A COMPONENT FAULT. THIS FAULT WAS RECOGNIZED BY THE DEVICE THROUGH THE SELF-TEST WHICH IS PERFORMED DURING POWER-UP WHEN IT IS SUPPLIED WITH GAS. THE DEVICE SHOULD HAVE BEEN SWITCHED ON AND CHECKED FOR FUNCTIONALITY BEFORE USE IN THE OPERATION. THE FOLLOWING INFORMATION IS STATED IN THE CORRESPONDING INSTRUCTIONS FOR USE OF THE DEVICE: "CHECK THE PRODUCT FOR THE FOLLOWING PROPERTIES, FOR EXAMPLE, BEFORE AND AFTER EVERY USE: FUNCTIONALITY, DAMAGE, CHANGES TO THE SURFACE, IN THE CASE OF SEVERAL COMPONENTS: COMPLETENESS AND CORRECT ASSEMBLY. DO NOT CONTINUE TO USE DAMAGES PRODUCTS." "SELF-TEST DURING POWER-UP, THE PROUCT PERFORMS A SELF-TEST WHEN IT IS SUPPLIED WITH GAS. IF THE SELF-TEST IS NEGATIVE, A CORRESPONDING ERROR MESSAGE IS DISPLAYED AND THE PRODUCT CANNOT BE USED PROPERLY." THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN "ERROR 3FD: POWERON TEST ERROR. LAPAROTOMY INSTEAD OF LAPAROSCOPY." SINCE THE DESCRIPTION INDICATES THAT A LAPAROTOMY HAD TO BE PERFORMED INSTEAD OF A LAPAROSCOPY, THIS EVENT HAS BEEN EVALUATED AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601058 ENDOFLATOR 50 LAPAROSCOPIC INSUFFLATOR FCX KARL STORZ SE & CO. KG UI500 04048551326657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other