BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPOINT ELECTRODE UNKNOWN PRODUCT

    MDR report key: 9243111 · Received October 25, 2019

    Report

    Report Number
    2210968-2019-89077
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    September 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    HIH
    PMA / PMN Number
    K040302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: REF GYNECOL OBSTET 7:169-173. (B)(4).

    Description of Event or Problem · 1

    TITLE: VERSAPOINT IN THE TREATMENT OF FOCAL INTRA-UTERINE PATHOLOGY IN AN OUTPATIENT CLINIC SETTING. THE AUTHORS DESCRIBED THEIR EXPERIENCE WITH THE VERSAPOINT SYSTEM (ETHICON) IN AN OUTPATIENT SETTING IN THE TREATMENT OF FOCAL INTRA-UTERINE PATHOLOGY. BETWEEN OCTOBER 1998 AND DECEMBER 1999, 632 FEMALE PATIENTS WERE SEEN IN THE OUTPATIENT HYSTEROSCOPY CLINIC IN WHICH SYMPTOM ASSESSMENT WAS CARRIED OUT WITH GYNAECOLOGICAL HISTORY, PELVIC ULTRASOUND EXAMINATION AND DIAGNOSTIC HYSTERSCOPY. OF THE 632, ONLY 125 FEMALE PATIENTS (MEDIAN AGE: 52.1 YEARS; AGE RANGE: 22 TO 77 YEARS) UNDERWENT THE TREATMENT USING VERSAPOINT SYSTEM (ETHICON). DIAGNOSTIC HYSTEROSCOPY WAS CARRIED OUT USING A 1.8 MM 0 DEGREE SEMI-RIGID FIBRE TELESCOPE WITH A DISPOSABLE SHEATH (VERSASCOPE; GYNECARE). THE SHEATH CONSISTS OF AN INFLOW CHANNEL WHICH HOUSES THE HYSTEROSCOPE AND ALLOWS FOR INFUSION OF SALINE. THE OUTFLOW CHANNEL FOR THE DISTENSION MEDIUM ALSO SERVES AS THE OPERATIVE CHANNEL FOR 2 MM INSTRUMENTS. VERSAPOINT SYSTEM (ETHICON) WAS USED FOR TREATMENT DURING THE DIAGNOSTIC HYSTEROSCOPY. ON ACTIVATION, A STEAM BUBBLE FORMS AT THE ELECTRODE TIP, WHICH UPON CONTACT WITH TISSUE CAUSES INSTANTANEOUS CELLULAR RUPTURE AND VAPORIZATION. REPORTED COMPLICATIONS INCLUDED PAINFUL DIAGNOSTIC HYSTEROSCOPY (N-?), PROCEDURE FAILED (N-15) IN WHICH 7 PATIENTS HAD THEIR SURGERY SUCCESSFULLY COMPLETED IN A SECOND SESSION AND 8 PATIENTS NEEDED ADMISSION FOR A DAY-CASE PROCEDURE UNDER GENERAL ANESTHESIA, ABDOMINAL CRAMPING (N-?) WHICH IMPROVED IMMEDIATELY AS THE SURGERY ENDED, POST OPERATIVE DISCOMFORT/PAIN (N-?) WHICH RESPONDED TO SIMPLE ANALGESIA AND 124 PATIENTS WERE COMFORTABLE GOING HOME WITHIN 1 HOUR AFTER THE PROCEDURE BUT 1 PATIENT REQUIRED ADMISSION FOR PAIN CONTROL AND WAS DISCHARGED HOME AFTER AN OVERNIGHT STAY, AND HEAVY BLEEDING (N-2) WHICH RESPONDED TO ORAL TRANEXAMIC ACID. IN CONCLUSION, THE VERSAPOINT BIPOLAR SYSTEM IS A VERSATILE NEW TECHNOLOGY, WHICH IS SAFE AND WELL TOLERATED IN THE OUTPATIENT SETTING. IT RDUCES THE NEED FOR GENERAL ANAESTHETIC IN PATIENTS WITH BENIGN UTERINE PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032451 VERSAPOINT ELECTRODE UNKNOWN PRODUCT HYSTEROSCOPE (AND ACCESSORIES) HIH ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention