BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESECTOSCOPE SHEATH, 26 FR.

    MDR report key: 17290686 · Received July 10, 2023

    Report

    Report Number
    9610617-2023-00906
    Event Type
    Death
    Date Received
    July 10, 2023
    Date of Event
    November 20, 2020
    Report Date
    June 21, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    NWW
    PMA / PMN Number
    K951343
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0074 CORRECTIVE ACTION 6. ACCORDING APPLIED PRESSURE (60MMHG): LOGFILE SHOWS INCREASE OF PRESSURE SETTINGS ABOVE 60MMHG (MORE DETAILS NOT LOGGED). ACCORDING FLUID DEFICIT OF 2.9L: HYSTEROMAT EASI (ROLLER PUMP) CAN BE USED FOR MONITORING OF FLUID SUPPLY, BUT NOT FLUID BALANCE MONITORING. WHEN MONITORING OF FLUID SUPPLY IS USED, A VISUAL AND ACOUSTICAL INFORMATION (EVENT 26) IS REPORTED TO THE USER, WHEN FLUID SUPPLY DECREASES 0.2L. BUT LOGFILE SHOWS NO ENTRY OF THE EVENT 26. - UNCLEAR WHETHER USER HAS NEEDED THIS FUNCTION. ACCORDING 26 FR. RESECTOSCOPE: IN A REAL TEST WITH A SIMILAR RESECTOSCOPE (26055SL, 22FR.) NO PROBLEMS HAVE BEEN OCCURRED. ACCORDING AIR EMBOLISM: THE IRRIGATION TUBING SET EXISTS OF A TRANSPARENT MATERIAL. SO USER CAN SEE BUBBLES, WHICH MAY BE OCCURRED. IFU INFORMS ABOUT RISKS. CONCLUSION: AFTER THE VISUAL INSPECTION INCL. PHOTO DOCUMENTATION, AN INITIAL TEST TOOK PLACE. THE DEVICE BEHAVED CORRECTLY. THE DEVICE WORKS CORRECTLY. THERE WERE NO INDICATIONS OF A FAULTY DEVICE BEHAVIOR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID ((B)(4)).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS EVENT WITH A RESECTOSCOPE SHEATH, 26 FR.. ACCORDING TO THE INFORMATION RECEIVED, THE INCIDENT HAPPENED AFTER A REMOVAL OF A 3.2CM G1 TYPE MYOMA. THE PRESSURE SETTINGS OF THE HYSTEROMAT E.A.S.I (ROLLER PUMP) WERE DURING THE WHOLE PROCEDURE ON 60 MMHG. AFTER 35 MINUTES AND A FLUID DEFICIT OF 2.9L THE SURGERY WAS STOPPED BY THE SURGEON. AT THAT TIME MOST OF THE MYOMA WAS REMOVED BUT THE OPERATION WAS STOPPED DUE TO THE FLUID DEFICIT. THE 26 FR. RESECTOSCOPE INCLUDING ITS SHEATH WAS REMOVED FROM THE PATIENT AND THE HYSTEROMAT E.A.S.I WAS NOT CONNECTED TO THE PATIENT ANYMORE. AFTER 1-2 MINUTES THE OXYGEN RATE OF THE PATIENT DECREASED DRAMATICALLY WHICH LED TO AN AIR EMBOLISM OF THE 50-YEAR-OLD PATIENT. THE 50-YEAR-OLD PATIENT DIED DUE TO THE AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655191 RESECTOSCOPE SHEATH, 26 FR. RESECTOSCOPE SHEATH, 26 FR. NWW KARL STORZ SE & CO. KG 26050SC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Death| O 26050SL RESECTOSCOPE SHEATH, 26 FR.| 26340001-1 HYSTEROMAT E.A.S.I. SET, SN: (B)(6).