BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPOINT ELECTRODE UNKNOWN PRODUCT

    MDR report key: 9183748 · Received October 14, 2019

    Report

    Report Number
    2210968-2019-88607
    Event Type
    Injury
    Date Received
    October 14, 2019
    Report Date
    September 16, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    HIH
    PMA / PMN Number
    K040302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION: CONCOMITANT PRODUCT - VERSAPOINT GENERATOR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: TRANSCERVICAL INCISION OF SEPTA. THIS RETROSPECTIVE STUDY AIMED TO EVALUATE FEASIBILITY AND CLINICAL VALUE OF HYSTEROSCOPIC BIPOLAR ELECTRIC VAPORIZATION TECHNIQUE (VERSAPOINT BIPOLAR ELECTROSURGICAL SYSTEM) USED IN TRANSCERVICAL INCISION OF SEPTA (TCIS) IN AN OUTPATIENT SETTING. FROM (B)(6) 2001 TO (B)(6) 2005, 447 PATIENTS WITH AN AVERAGE AGE OF 29.17 ± 4.34 YEARS (RANGE 21¿53 YEARS) UNDERWENT HYSTEROSCOPIC TCIS. MICROSCISSORS WAS USED FOR 55 PATIENTS, MONOPOLAR ELECTRIC NEEDLE WAS USED FOR 15 PATIENTS, MONOPOLAR ELECTRIC LOOP WAS USED FOR 11 PATIENTS AND BIPOLAR ELECTRIC VAPORIZATION ELECTRODE WAS USED FOR 366 PATIENTS. BIPOLAR ELECTRIC RESECTOSCOPE (JOHNSON & JOHNSON INC., USA) AND VERSAPOINT BIPOLAR ELECTROSURGICAL SYSTEM (GYNECARE; ETHICON INC., NJ, USA) INCLUDED SPECIAL BIPOLAR ELECTRICAL GENERATOR WITH AN OUTPUT POWER AT 40¿60 W AND TWO TYPES OF EVAPORATION ELECTRODES: HELICAL ELECTRODE AND SPRING ELECTRODE (1.7 MM OUTER DIAMETERS) WITH THE FORMER USED IN ACCURATE VAPORIZATION INCISION AND THE LATTER USED IN DIFFUSE TISSUE VAPORIZATION. COMPLICATIONS INCLUDED UTERINE PERFORATION WHICH WAS TREATED WITH UTERINE CONTRACTION AGENTS; BLOOD LOSS AND INJURY TO BLOOD VESSELS IN MUSCULAR TISSUE OF UTERINE FUNDUS WHICH WERE TREATED WITH UTERINE CONTRACTION AGENTS AND HEMOSTATICS; POSTOPERATIVE PELVIC INFECTION AND URETHRAL INFECTION WHICH WERE TREATED WITH ANTIBIOTICS. IN CONCLUSION, HYSTEROSCOPIC BIPOLAR ELECTRIC VAPORIZATION TCIS COULD BE CARRIED OUT SAFELY AND EFFICACIOUSLY IN AN OUTPATIENT SETTING, BY USING SMALLER HYSTEROSCOPE AND BIPOLAR ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980449 VERSAPOINT ELECTRODE UNKNOWN PRODUCT HYSTEROSCOPE (AND ACCESSORIES) HIH ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VERSAPOINT GENERATOR UNKNOWN PRODUCT