BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPOINT ELECTRODE UNKNOWN PRODUCT

    MDR report key: 9239188 · Received October 25, 2019

    Report

    Report Number
    2210968-2019-89055
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    September 27, 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). 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: REPRODUCTIVE SCIENCES 00(0) 1-7, DOI: 10.1177/1933719112466308. REPRODUCTIVE SCIENCES PUBLISHED ONLINE 10 DECEMBER 2012. (B)(4).

    Description of Event or Problem · 1

    TITLE: A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS WHETHER ANTIBIOTIC ADMINISTRATION SHOULD BE RECOMMENDED DURING OFFICE OPERATIVE HYSTEROSCOPY. THIS MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY AIMED TO ASSESS THE INCIDENCE OF INFECTIOUS COMPLICATIONS AND THE PROTECTIVE EFFECT OF PROPHYLACTIC ANTIBIOTIC DURING OPERATIVE HYSTEROSCOPIC PROCEDURES IN AN OFFICE SETTING. BETWEEN JANUARY AND OCTOBER 2010, A TOTAL OF 1046 PATIENTS UNDERGOING OFFICE HYSTEROSCOPY DURING THE IMMEDIATE POSTMENSTRUAL PHASE OF THE MENSTRUAL CYCLE (6TH-10TH DAY, COMPUTED ON THE BASE OF THE LAST MENSTRUAL PERIOD AS REFERRED BY PATIENTS) WERE INCLUDED IN THE STUDY. THE PATIENTS WERE RANDOMLY ASSIGNED TO EITHER REFERENCE GROUP (N=523; MEAN AGE OF 36.3 YEARS, MEAN BMI OF 24.8) WHERE 1 G OF CEFAZOLIN WAS INTRAMUSCULARLY (IM) ADMINISTERED DURING HYSTEROSCOPIC PROCEDURE; AND STUDY GROUP (N=523; MEAN AGE OF 42.1 YEARS, MEAN BMI OF 26.6), WHERE PATIENTS WERE ADMINISTERED WITH 10 ML OF ISOTONIC SODIUM CHLORIDE SOLUTION (THE PLACEBO) DURING HYSTEROSCOPIC PROCEDURE. OPERATIVE PROCEDURES INCLUDE POLYPECTOMY, SYNECHIOLYSIS, METROPLASTY, AND MYOMECTOMY. AFTER PANORAMIC VISUALIZATION OF THE ENTIRE UTERINE CAVITY, THE OPERATIVE PROCEDURES WERE PERFORMED WITH STANDARD TECHNIQUES USING GRASPING FORCEPS, SCISSORS, AND BIPOLAR ELECTRODES (VERSAPOINT GYNECARE, ETHICON). COMPLAINTS INCLUDED POSTSURGICAL INFECTIOUS COMPLICATIONS (N=12). IN DETAILS, 7 PATIENTS WHO HAD COMPLICATIONS BELONG TO THE STUDY (UNTREATED) GROUP [POLYPECTOMY (N=2), SYNECHIOLYSIS (N=1), METROPLASTY (N=2), MYOMECTOMY (N=1), OTHERS (N=1)] AND 5 FROM THE REFERENCE GROUP [POLYPECTOMY (N=3), METROPLASTY (N=1), MYOMECTOMY (N=1)]. ANTIBIOTICS WERE PRESCRIBED IN ALL CASES OF POSTSURGICAL INFECTION AND THE INFECTIVE PROCESS RESOLVED IN FEW DAYS. THE RESULTS PRESENTED IN THIS STUDY WOULD SUPPORT THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS RECOMMENDATION NOT TO PRESCRIBE ROUTINE ANTIBIOTIC ADMINISTRATION IN THE CASE OF HYSTEROSCOPIC SURGERY, CONSIDERING THE LOW RISK OF INFECTIOUS COMPLICATIONS AFTER HYSTEROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033103 VERSAPOINT ELECTRODE UNKNOWN PRODUCT HYSTEROSCOPE (AND ACCESSORIES) HIH ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention