BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 24327649 · Received February 12, 2026

    Report

    Report Number
    2210968-2026-01601
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    September 1, 2025
    Report Date
    February 12, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: J OBSTET GYNAECOL RES. 2025 SEP;51(9): E70068. HTTPS://DOI.ORG/10.1111/JOG.70068. (B)(6).

    Description of Event or Problem · 0

    TITLE: COMPARISON OF SURGICAL OUTCOMES BETWEEN ROBOTIC AND LAPAROSCOPIC SACROCOLPOPEXY WITH CONCOMITANT TOTAL HYSTERECTOMY FOR PELVIC ORGAN PROLAPSE: A RETROSPECTIVE COHORT STUDY. THE AIM OF THIS STUDY IS TO COMPARE SHORT- AND LONG-TERM SURGICAL OUTCOMES BETWEEN ROBOTIC SACROCOLPOPEXY (RSC) AND LAPAROSCOPIC SACROCOLPOPEXY (LSC), PERFORMED WITH CONCOMITANT TOTAL HYSTERECTOMY, IN PATIENTS WITH SYMPTOMATIC PELVIC ORGAN PROLAPSE (POP). THIS RETROSPECTIVE COHORT STUDY INCLUDED 167 WOMEN WHO UNDERWENT RSC (N = 113) OR LSC (N = 54) WITH HYSTERECTOMY FOR UTERINE PROLAPSE AT KAWASAKI MEDICAL UNIVERSITY BETWEEN MARCH 2020 AND DECEMBER 2024. FOR CONCOMITANT HYSTERECTOMIES, THE PROCEDURE WAS COMPLETED VAGINALLY AFTER ROBOTIC DISSECTION OF THE ROUND AND INFUNDIBULOPELVIC LIGAMENTS. AFTER HYSTERECTOMY, TENSION WAS APPLIED AGAIN WITH A VAGINAL MANIPULATOR, THE VESICOVAGINAL, RECTOVAGINAL, AND PRESACRAL SPACES WERE DISSECTED, AND SPREAD TO THE PLANE TO WHICH THE MESH WAS SUTURED. NONABSORBABLE RUNNING SUTURES (0 ETHIBOND EXCEL SH, ETHICON, INC., SOMERVILLE, NJ) WERE USED TO SECURE THE ANTERIOR LONGITUDINAL LIGAMENT AT THE SACRAL PROMONTORY. THIS SUTURE MATERIAL WAS SELECTED TO PROVIDE PROLONGED MECHANICAL SUPPORT AND MAINTAIN DURABLE FIXATION OF THE MESH, THEREBY REDUCING THE RISK OF POSTOPERATIVE POP RECURRENCE. SELF-CUT POLYPROPYLENE MESH (GYNEMESH, ETHICON, INC., SOMERVILLE, NJ) WAS ATTACHED TO THE ANTERIOR AND POSTERIOR VAGINAL WALLS USING AT LEAST EIGHT NONABSORBABLE SUTURES PER WALL WITH INTRACORPOREAL KNOT-TYING TO ENSURE SECURE ANCHOR ING. AFTER APPROPRIATE TENSIONING, THE MESH WAS SECURED TO THE ANTERIOR LONGITUDINAL LIGAMENT, AND THE PERITONEUM WAS REAPPROXIMATED WITH ABSORBABLE SUTURES (2-0 VICRYL,ETHI CON, INC., SOMERVILLE, NJ). REPORTED COMPLICATIONS INCLUDE: 0 ETHIBOND EXCEL SH. RECURRENCE OF URINARY INCONTINENCE (N=2). RECURRENCE OF ORGAN PROLAPSE (N=1). SELF-CUT POLYPROPYLENE MESH (GYNEMESH, ETHICON). RECURRENCE OF MESH EROSION (N=2). RECURRENCE OF URINARY INCONTINENCE (N=2). RECURRENCE OF ORGAN PROLAPSE (N=1). 2-0 VICRYL (ETHICON). RECURRENCE OF URINARY INCONTINENCE (N=2). RECURRENCE OF ORGAN PROLAPSE (N=1). IN CONCLUSION, WE EVALUATED BOTH THE SHORT- AND LONG TERM POSTOPERATIVE OUTCOMES OF CONCOMITANT TOTAL HYSTERECTOMY PERFORMED DURING LSC AND RSC. THE SHORT-TERM OUTCOMES REVEALED LONGER OPERATIVE TIMES AND GREATER CERVICAL TRACTION IN THE RSC GROUP THAN IN THE LSC GROUP. HOWEVER, THE LONG-TERM OUTCOMES SHOWED NO DIFFERENCE IN PROLAPSE RECURRENCE, INCLUDING MESH EROSION, URINARY INCONTINENCE, AND ORGAN PROLAPSE, BETWEEN THE TWO GROUPS. WHILE DATA ON RECURRENCE AFTER SIMULTANEOUS HYSTERECTOMY IN LSC AND RSC REMAIN LIMITED, OUR FINDINGS INDICATE THAT THE RECURRENCE RATES ARE CONSISTENT WITH THOSE OF PREVIOUS REPORTS. FURTHER RESEARCH IS REQUIRED TO CLARIFY THE LONG TERM PROGNOSTIC VALUE OF CONCOMITANT HYSTERECTOMY USING BOTH APPROACHES. ON THE OTHER HAND, FOR WOMEN UNDERGOING SURGICAL TREATMENT FOR POP, THE CHOICE BETWEEN PRESERVING OR REMOVING THE UTERUS SHOULD BE TAILORED TO THE INDIVIDUAL, BASED ON DETAILED PREOPERATIVE COUNSELING. THIS COUNSELING SHOULD BE PATIENT-CENTERED AND ADDRESS SEVERAL IMPORTANT CONSIDERATIONS, INCLUDING FUTURE FERTILITY DESIRES, THE EMOTIONAL AND PSYCHOLOGICAL IMPACT OF UTERINE REMOVAL ON BODY IMAGE AND FEMININITY, THE RISK OF DEVELOPING UTERINE OR CERVICAL CANCER, THE POTENTIAL INFLUENCE OF SURGERY ON SEXUAL FUNCTION, AND THE LIMITED LONG-TERM DATA REGARDING RECURRENCE OUTCOMES FOR EACH SURGICAL APPROACH. ULTIMATELY, THE TYPE OF SURGICAL INTERVENTION SHOULD BE A PATIENT-BASED DECISION, REFLECTING BOTH CLINICAL INDICATIONS AND THE INFORMED PREFERENCES OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384389 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other