BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50

    MDR report key: 21048039 · Received December 31, 2024

    Report

    Report Number
    9610617-2024-00555
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    December 17, 2024
    Report Date
    July 2, 2025
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTION D9 TO REFLECT THAT THE PRODUCT WAS RETURNED FOR EVALUATION ON JANUARY 10,2025. THE INVESTIGATION IS NOT COMPLETED YET. THE INVESTIGATION RESULTS ARE PENDING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PRODUCT A: 031622-10 - INSUFFLATION TUBING SET WITH GAS FILTER. PRODUCT B: UI500 - ENDOFLATOR 50. PRODUCT A: INSUFFLATION TUBING SET. AS DESCRIBED IN THE INVESTIGATION, NO FAILURE WAS FOUND. THE TUBING SET WAS INSPECTED AND CONFIRMED TO BE FULLY FUNCTIONAL AND OPERATING AS INTENDED. PRODUCT B: ENDOFLATOR 50. THE ERROR CODES PROVIDED BY THE CUSTOMER ARE NOT RECOGNIZED WITHIN THE DEVICE'S DEFINED FAILURE CODING SYSTEM. BASED ON THE REPORTED SYMPTOMS AND FINDINGS, THE MOST PROBABLE ROOT CAUSE IS A TEMPORARY BLOCKAGE IN THE TUBING OR INSTRUMENT PATH,SUCH AS A CLOSED STOPCOCK OR FLOW RESTRICTION. THIS ASSUMPTION IS SUPPORTED BY THE FACT THAT NO DEFECTS WERE FOUND IN THE TUBING SET ITSELF. THE REPORTED ISSUE IS MOST LIKELY DUE TO A TEMPORARY USE-RELATED CONDITION, SUCH AS A BLOCKAGE IN THE GAS PATH, RATHER THAN A DEVICE OR COMPONENT FAILURE. NO EVIDENCE OF A MANUFACTURING DEFECT OR LABELLING DEFICIENCY WAS FOUND. NO MANUFACTURING DEFECTS WERE IDENTIFIED DURING THE INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED ON TUESDAY (B)(6) 2024, DURING A CRITICAL STAGE OF A BARIATRIC GASTRIC BYPASS WHEN SUDDENLY LOST GAS PRESSURE AND THE ERROR CODE 328 CAME UP ON THE SCREEN, THE ERROR CODE 228 ALSO CAME UP. FOLLOWED THE INSTRUCTIONS TO TURN THE UNIT OFF AND THEN BACK ON AGAIN WHICH WORKED FOR ABOUT 10 MINUTES UNTIL THE SAME INCIDENT REOCCURRED.THE TUBING WAS CHANGED AND THE SURGERY WAS COMPLETED WITHOUT INCIDENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134313 ENDOFLATOR 50 ENDOFLATOR 50 FCX KARL STORZ SE & CO. KG UI500 04048551326657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 031622-01- INSUFFLATION TUBING SET WITH GAS FILTER.