BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYSTEROMAT E.A.S.I. SCB

    MDR report key: 17418279 · Received July 28, 2023

    Report

    Report Number
    9610617-2023-00904
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    November 27, 2020
    Report Date
    July 24, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    NWW
    PMA / PMN Number
    K951343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 22-0074 CORRECTIVE ACTION 6. THE DEVICE SHOWS A FAULTY BEHAVIOR DUE TO A DEFECTIVE ASSEMBLY/TEMPERATURE SENSOR 1983491 (PCB/ASM/TEMPERATURE SENSOR PUMPEN MOTOR) OF THE IRRIGATION PUMP MOTOR. THE PUMP ACTIVATION HAS BEEN ABORTED AFTER A SHORT TIME AND THE INTERVENTION HAS BEEN MORE DIFFICULT AND LONGER. A FSN (#200829959) WITH THE INSTRUCTION TO NO LONGER USE THE DEVICE WAS DISTRIBUTED TO OUR DISTRIBUTOR AND ALSO MADE AVAILABLE ON THE MOH'S WEBSITE ON 24-NOV-2020 - DESPITE THIS, THE DEVICE WAS USED ON 27-NOV-2020. AS CLEARLY STATED IN FSN: RISKS FOR PATIENTS/USERS/THIRD PARTIES IF THE PRODUCTS ARE USED AGAIN: THE DISPLAYED PRESSURE VALUE COULD DIFFER FROM THE ACTUAL INTRACAVITARY PRESSURE VALUE. THERE IS A RISK THAT A PATIENT MAY BE EXPOSED TO A HIGHER PRESSURE THAN INTENDED. DUE TO THE POSSIBLY INCREASED PRESSURE, THE GENERAL RISKS OF HYSTEROSCOPY ARE MORE LIKELY TO OCCUR THAN WHEN COMPARABLE PUMP SYSTEMS ARE USED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID ( (B)(6) ).

    Description of Event or Problem · 0

    AS REPORTED (ANALOGOUS TRANSLATION FROM ITALIAN ORIGINAL DESCRIPTION RECEIVED): DURING MYOMECTOMY SURGERY, HYSTEROSCOPY, DIFFICULT DISTENSION OF THE UTERINE CAVITY, INSUFFICIENT INSUFFLATION PRESSURE, INABILITY TO MANUALLY SET THE INTRAUTERINE PRESSURE WITH VERY POOR SEALING OF THE SAME AND BLEEDING EXCEEDING EXPECTATIONS THAT REQUIRED TRANSFUSION OF 1 BAG OF CONCENTRATED RED CELLS IN THE POST-OPERATIVE PERIOD. THE PROCEDURE WAS COMPLETED WITH EXTREME DIFFICULTY, WITH SIGNIFICANT LENGTHENING OF THE SURGICAL TIME, WITHOUT HOWEVER FURTHER PROBLEMS FOR THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967891 HYSTEROMAT E.A.S.I. SCB HYSTEROMAT E.A.S.I. SCB NWW KARL STORZ SE & CO. KG 26340020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 031217-01 - TUBING SET, HYS/URO E.A.S.I. (SUCTION)| 26053CB - INNER SHEATH F. RESECT. SHEATH, 15 FR.| 26153BI - BETTOCCHI® INNER SHEATH| 26153BO - BETTOCCHI® OUTER SHEATH