BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 16553876 · Received March 16, 2023

    Report

    Report Number
    2210968-2023-01747
    Event Type
    Injury
    Date Received
    March 16, 2023
    Date of Event
    November 5, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CLINICAL CODE: E2402 ¿ RECURRENCE OF CYSTOCELE AND RECTOCELE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-01746 AND 2210968-2023-01747. CITATION: GYNECOLOGY AND MINIMALLY INVASIVE THERAPY (OCTOBER-DECEMBER 2021);10 (4):221-225. DOI: 10.4103/GMIT.GMIT_127_20. PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF SURGICAL RESULTS AND POSTOPERATIVE RECURRENCE RATES BY LAPAROSCOPIC SACROCOLPOPEXY WITH OTHER SURGICAL PROCEDURES FOR MANAGING PELVIC ORGAN PROLAPSE. THE AIM OF THIS STUDY WAS TO PRESENT THE SURGICAL OUTCOME AND RECURRENCE RATE OF LSC AND COMPARED THE DATA OF LSC WITH THAT OF OTHER SURGICAL PROCEDURES FOR MANAGING PELVIC ORGAN PROLAPSE (POP) TO EXAMINE THE EFFECTIVENESS OF LSC OVER OTHER THEM. FROM 2006 TO 2019, A TOTAL OF 138 CASES (MEAN AGE WAS 69 YEARS; MEAN BMI WAS 26) OF LAPAROSCOPIC SACROCOLPOPEXY (LSC) WERE COMPARED WITH OTHER CONVENTIONAL PROCEDURES, NAMELY 30 CASES (MEAN AGE WAS 70 YEARS; MEAN BMI WAS 24.1) OF TOTAL VAGINAL HYSTERECTOMY (TVH) COMBINED WITH COLPORRHAPHY ANTERIOR AND POSTERIOR, 66 CASES (MEAN AGE OF 63 YEARS; MEAN BMI WAS 23.6) OF THE MANCHESTER OPERATION, AND 68 CASES (MEAN AGE OF 75 YEARS; MEAN BMI WAS 23.6) OF COLPOCLEISIS. IN THE LSC PROCEDURE, AN ETHIBOND® (JOHNSON AND JOHNSON JAPAN, TOKYO, JAPAN) SUTURE (NO. 0) WAS INSERTED THROUGH THE ANTERIOR LONGITUDINAL LIGAMENT AND LEFT UNTIED. THE RETROPERITONEUM WAS CUT ON THE MEDIAL SIDE OF THE RIGHT UTEROSACRAL LIGAMENT, AND A SUBTOTAL HYSTERECTOMY AND BILATERAL ADNEXECTOMY WERE THEN PERFORMED. THE UTERUS WAS REMOVED USING A MORCELLATOR. THE RECTOVAGINAL SPACE WAS EXPOSED, AND A POSTERIOR COLPORRHAPHY WAS PERFORMED USING A V-LOC® (NO. 2-0) (COVIDIEN JAPAN, TOKYO, JAPAN)SUTURE. THE VESICOVAGINAL SPACE WAS SEPARATED, AND A PIECE OF MESH (GYNEMESH®, JOHNSON AND JOHNSON JAPAN, TOKYO, JAPAN) WAS INSERTED AND PLACED ON THE ANTERIOR WALL OF THE VAGINA. THE MESH WAS SUTURED WITH SEVEN STITCHES USING ETHIBOND® SUTURES (NO. 3-0) ON THE VAGINAL WALL AND THE CERVIX OF THE UTERUS, WHICH WAS THEN LIFTED FOR STITCHING WITH A PREMADE UNTIED SUTURE IN THE ANTERIOR LONGITUDINAL LIGAMENT. THE PERITONEUM WAS FULLY CLOSED USING AN ABSORBABLE SUTURE TO COMPLETE THE SURGERY. REPORTED COMPLICATIONS INCLUDE RECURRENCE OF CYSTOCELE (N=2) AND RECURRENCE OF RECTOCELE (N=2). IN CONCLUSION, LSC SEEMS TO BE AN EFFECTIVE SURGICAL OPTION THAT REQUIRES A HIGHER SKILL LEVEL THAN OTHER SURGICAL METHODS AND HAS A LONGER OPERATIVE TIME, LESSER OPERATIVE INVASION, AND A LOWER LONG-TERM RECURRENCE RATE. WE WILL ACTIVELY RECOMMEND LSC TO THOSE WHEN APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828567 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention