BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLATOR 50, W/INTEGRATED SCB MODULE

    MDR report key: 17597085 · Received August 22, 2023

    Report

    Report Number
    9610617-2023-00214
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 8, 2023
    Report Date
    October 12, 2023
    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
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING OF THE REPORTED ISSUE BY OUR SALES REP IN THE FIELD, THEY FOUND THE SAME ISSUE OCCURRED EVEN AFTER THEY SWAPPED OUT WITH ANOTHER INSUFFLATOR DEVICE. IT WAS THEN DETERMINED THAT THE CAUSE OF THE ISSUE WAS MOST LIKELY DUE TO THE ROOM'S CO2 INTERNAL HOSE. FACILITIES EVALUATED IT AND THE DEVICE HAS NOT HAD ANY ISSUES MAINTAINING PRESSURE SINCE. THEREFORE, CUSTOMER WILL NOT RETURN THE DEVICE TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A LAPAROSCOPIC PROCEDURE ON (B)(6) 2023, THE DEVICE WAS NOT HOLDING THE PRESSURE IN THE MIDDLE OF THE CASE. CUSTOMER STATED THAT THE PROCEDURE WAS COMPLETED WITH A BACK-UP UNIT. THERE WAS NO PATIENT INJURY, ONLY A SLIGHT DELAY TO THE CASE WHEN THEY TRIED TO BRING IN THE BACK-UP UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311448 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