BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SCOPE CLEANOR

    MDR report key: 17582906 · Received August 21, 2023

    Report

    Report Number
    3010437008-2023-00003
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    June 22, 2017
    Report Date
    June 20, 2023
    Manufacturer
    ADVANCED MEDICAL DESIGN CO., LTD.
    Product Code
    NWV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    POSSIBLE FAILURE SITUATION WHICH CAUSES THE CUSTOMER COMPLAINT ACCORDING TO THE INFORMATION GIVEN FROM ORC, THE TROCAR WAS INTRODUCED VERY SHALLOWLY. THE END OF TROCAR WAS PLACED BETWEEN THE PERITONEUM AND THE FACIAL MUSCLE, INSTEAD OF APPROACHING TO THE ABDOMINAL CAVITY. THEREFORE, WHEN THE PHYSICIAN USES THE TROCAR CLEANOR TO CLEAN THE TROCAR, THERE IS A POSSIBLE SITUATION THAT THE END OF SWAB HEAD WAS STUCK BETWEEN THE TROCAR AND THE PERITONEUM/FACIAL MUSCLE, THEN THE TROCAR CLEANOR WAS REMOVED FROM THE TROCAR. THE SPONGE OF THE TROCAR CLEANOR SHOULD BEAR A RESIDUAL PULL FORCE DURING THE REMOVAL STEP OF THE TROCAR CLEANOR FROM THE TROCAR. THAT IS THE MAIN POSSIBLE REASON THAT THE SWAB OF THE TROCAR CLEANOR WAS CUT AND APPROXIMATE 3/4 SPONGE LEFT IN THE PERITONEUM/FACIAL MUSCLE OF THE PATIENT. SUMMARY: ACCORDING TO THE PREVIOUS ANALYSIS, THE PULL STRENGTH OF TROCAR CLEANOR MEETS THE PRODUCT SPECIFICATION >= 1 KGF) AND THE PRODUCT SPECIFICATION WHICH ESTABLISHED, IN THE BEGINNING, COULD MEET THE CLINICAL OPERATION SITUATION PURPOSE. THE POSSIBLE FAILURE SITUATION OF THE CUSTOMER COMPLAINT IS THAT THE END OF SWAB HEAD WAS STUCK BETWEEN THE TROCAR AND THE PERITONEUM/FACIAL MUSCLE, THEN THE TROCAR CLEANOR WAS REMOVED FROM THE TROCAR AND RESIDUAL PULL FORCE OF THE TROCAR CLEANOR EXISTS. SINCE THE TROCAR SHOULD INTRODUCE INTO THE ABDOMEN CAVITY OF THE PATIENT FIRST, THEN THE TROCAR CLEANOR SHOULD BE USED TO CLEAN THE BLOOD WHICH LEFT ON THE INNER SURFACE OF THE TROCAR. IF THE TROCAR DOES NOT PASS THROUGH THE ABDOMEN CAVITY, IT MAY CAUSE THAT THE TROCAR CLEANOR WOULD TOUCH THE PERITONEUM/FACIAL MUSCLE. THE CONTINUED SIDE EFFECT MAY CAUSE THE FAILURE SITUATION.

    Description of Event or Problem · 0

    DUE TO A 6-LITER OVARIAN CYST, THE INITIAL TROCAR WE PLACED VERY SHALLOWLY. AFTER THE TROCAR WAS REMOVED FROM THE CANNULA, THE 5/8MM SWAB WAS USED TO CLEAN THE CANNULA PRIOR TO INSERTING THE SCOPE. AFTER THIS WAS DONE, THE STAFF IMMEDIATELY NOTICED THAT APPROXIMATELY 3/4THS OF THE FOAM TIP HAD TORN LOOSE. THE SCOPE WAS INSERTED AND THE SURGEON BEGAN TO LOOK FOR THE MISSING FOAM PIECE. AFTER APPROXIMATELY 90 MINUTES OF SEARCHING AND X-RAYS, THEY COMPLETED THE OVARIAN CYST PROCEDURE AND THEN PERFORMED A SMALL LAPAROTOMY INCISION TO FURTHER INVESTIGATE FOR THE FOAM PIECE. THEY FOUND IT BETWEEN THE PERITONEUM AND THE FACIAL MUSCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490664 SCOPE CLEANOR SCOPE + TROCAR CLEANING DEVICE NWV ADVANCED MEDICAL DESIGN CO., LTD. SC-01 1611054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other