BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPOINT SPRING TIP ELECTRD

    MDR report key: 9172623 · Received October 9, 2019

    Report

    Report Number
    2210968-2019-88507
    Event Type
    Injury
    Date Received
    October 9, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AUTHORS : ALESSANDRO CASA, M.D., FRANCESCO SESTI, M.D., MASSIMILIANO MARZIALI, M.D., LORENZA GULEMÌ, M.D., AND EMILIO PICCIONE, M.D. CITATION: J AM ASSOC GYNECOL LAPAROSC. 2003; 10(2): 219¿222.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: TRANSVAGINAL HYDROLAPAROSCOPIC OVARIAN DRILLING USING BIPOLAR ELECTROSURGERY TO TREAT ANOVULATORY WOMEN WITH POLYCYSTIC OVARY SYNDROME. THE OBJECTIVES OF THIS STUDY WAS TO VERIFY THE VALUE, FEASIBILITY, AND RELIABILITY OF TRANSVAGINAL HYDROLAPAROSCOPIC OVARIAN DRILLING USING THE BIPOLAR VERSAPOINT SYSTEM (ETHICON) TO TREAT CLOMIPHENE-RESISTANT, ANOVOLUNTARY WOMEN WITH POLYCYSTIC OVARY SYNDROME. A TOTAL OF 28 FEMALE PATIENTS (AGE: 29.3 ± 4.2 YEARS; BMI: 25.3 ± 5.4) WERE INCLUDED IN THE STUDY. THE BIPOLAR GYNECARE VERSAPOINT ELECTROSURGICAL SYSTEM (ETHICON) WAS USED DURING THE PROCEDURE. REPORTED COMPLICATIONS INCLUDED OVARIAN BLEEDING (N-1) WHICH REQUIRED CONVERSION TO CONVENTIONAL LAPAROSCOPY AND WAS EXCLUDED FROM THE STUDY AND LYSIS OF THE PERI-OVARIAN ADHESIONS (N-1) WHICH WAS ASSOCIATED WITH THE OVARIAN DRILLING. TRANSVAGINAL HYDROLAPAROSCOPIC OVARIAN DRILLING WITH THE BIPOLAR VERSAPOINT SYSTEM ALLOWED SAFE MANAGEMENT IN THESE ANOVULATORY WOMEN WITH PCOS RESISTANT TO MEDICAL TREATMENT. FURTHER RANDOMIZED TRIALS BETWEEN LAPAROSCOPIC AND HYDROLAPAROSCOPIC OVARIAN DRILLING ARE NECESSARY TO DEFINE MORE PRECISELY THE PROCEDURES¿ RESPECTIVE INDICATIONS AND LIMITS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967021 VERSAPOINT SPRING TIP ELECTRD HYSTEROSCOPE (AND ACCESSORIES) HIH ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention