BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16574119 · Received March 20, 2023

    Report

    Report Number
    2210968-2023-01804
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    August 16, 2022
    Report Date
    March 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS ALSO CAPTURED VIA 2210968-2023-01805. CITATION: ARCHIVES OF GYNECOLOGY AND OBSTETRICS (2022); 306:2009¿2015. HTTPS://DOI.ORG/10.1007/S00404-022-06735-6.

    Description of Event or Problem · 0

    TITLE: SINGLE-CENTER STUDY FOR ROBOTIC-ASSISTED LAPAROSCOPIC SACROPEXIES: A ONE-FITS-ALL STRATEGY FOR PELVIC ORGAN PROLAPSE? THE AIM OF THIS MONOCENTRIC RETROSPECTIVE STUDY IS TO COMPARE THE SURGICAL RESULTS AND OUTCOMES OF ROBOTIC-ASSISTED SACROPEXIES. A TOTAL OF 49 WOMEN [MEAN AGE WAS 63.5 YEARS (SD 10.7); MEAN BMI WAS 24.7 KG/M2 (SD 3.8)] WHO WERE TREATED IN THE DEPARTMENT OF GYNECOLOGY AND OBSTETRICS AT THE UNIVERSITY HOSPITAL OF ESSEN, GERMANY, BETWEEN 2012 AND 2019, WERE INCLUDED IN THE STUDY. ALL PATIENTS WERE OPERATED ON DUE TO SYMPTOMATIC POP STAGE II OR GREATER UTERINE/VAGINAL VAULT PROLAPSE IN THE DEPARTMENT. PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE TYPE OF ROBOTIC-ASSISTED SACROPEXY: PATIENTS WITH A HISTORY OF HYSTERECTOMY RECEIVED ROBOTIC-ASSISTED SACROCOLPOPEXY (RSCP; N = 19), WHILE PATIENTS WITH SUBTOTAL HYSTERECTOMY RECEIVED ROBOTIC-ASSISTED CERVICOSACROPEXY (RCSP; N = 30). A COMPETITOR'S Y-SHAPED MESH IS PLACED ON THE POSTERIOR AND ANTERIOR VAGINAL WALL AND ATTACHED WITH AN ABSORBABLE SUTURE (VICRYL 2¿0, JOHNSON & JOHNSON, NEW BRUNSWICK, NJ, USA). THE FRONT AND POSTERIOR LEG OF THE MESH ARE ATTACHED TO THE CERVIX OR FIXED ON THE VAGINAL WALL. THE Y-SHAPED MESH IS FIXED AT THE LEVEL OF ANTERIOR LONGITUDINAL LIGAMENTS S1 OR S2 USING 2 NON-ABSORBABLE SUTURES (ETHIBOND 0, ETHICON, RARITAN, NJ, USA). SUBSEQUENTLY, THE PERITONEUM OVER THE MESH IS CLOSED AGAIN USING ABSORBABLE SUTURES. THE MEAN FOLLOW-UP TIME WAS 56.2 MONTHS (SD 26.5). REPORTED COMPLICATIONS INCLUDE RECURRENCE OF PROLAPSE (N=3) AND REOPERATION DUE TO SYMPTOMS WAS REQUIRED. IN CONCLUSION, THE MONOCENTRIC LONG-TERM DATA CONFIRM THAT RSP IS A SAFE AND EFFECTIVE METHOD OF SURGICAL POP TREATMENT, REGARDLESS OF THE SITE OF THE ANATOMICAL COMPARTMENT. IN COMPARISON TO RSCP, RCSP IS ASSOCIATED WITH A LOWER IMPACT OF POP SYMPTOMS ON PATIENTS¿ QUALITY OF LIFE WITH A TENDENCY TO SLIGHTLY LOWER RATES OF POP RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776317 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention