BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 24500702 · Received March 3, 2026

    Report

    Report Number
    2210968-2026-02212
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    July 9, 2025
    Report Date
    March 3, 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: MEDICINA (KAUNAS). 2025 JUL 9;61(7):1242. HTTPS://DOI.ORG/10.3390/MEDICINA61071242 PMID: 40731871; PMCID: PMC12299456.

    Description of Event or Problem · 0

    TITLE: FEASIBILITY AND CLINICAL OUTCOMES OF ROBOT-ASSISTED SACROCOLPOPEXY USING AUTOLOGOUS ROUND LIGAMENT GRAFTS: A NOVEL NON-MESH SURGICAL APPROACH FOR PELVIC ORGAN PROLAPSE. THE AIM OF THIS STUDY IS TO EVALUATE THE FEASIBILITY AND CLINICAL OUTCOMES OF A NOVEL NON MESH ROBOT-ASSISTED SACROCOLPOPEXY (RSC) USING AUTOLOGOUS ROUND LIGAMENT (ARL) GRAFTS IN PATIENTS WITH PELVIC ORGAN PROLAPSE (POP). THIS RETROSPECTIVE STUDY INCLUDED 92 PATIENTS WHO UNDERWENT NON-MESH RSC WITH ARL GRAFTS AT KAGOSHIMA UNIVERSITY HOSPITAL BETWEEN AUGUST 2020 AND JUNE 2024. ALL PROCEDURES WERE PERFORMED USING EITHER THE DA VINCI XI (INTUITIVE SURGICAL, SUN NYVALE, CA, USA) OR THE HINOTORI SURGICAL ROBOT SYSTEM (MEDICAROID CORPORATION, KOBE, JAPAN). AS PART OF THE PROCEDURE, ALL PATIENTS UNDERWENT TOTAL HYSTERECTOMY WITH OR WITHOUT BILATERAL SALPINGO-OOPHORECTOMY. BOTH ROUND LIGAMENTS WERE HARVESTED AT THEIR MAXIMUM AVAILABLE LENGTH AND EXTRACTED THROUGH THE TROCAR FOR EXTRACORPOREAL PREPARATION. THE TWO LIGAMENTS WERE ALIGNED END-TO-END, REINFORCED BY FOLDING, AND SUTURED USING 2-0 ETHIBOND THREAD TO CREATE AN ARL GRAFT. FOLLOWING VAGINAL CUFF CLOSURE, ONE END OF THE ARL WAS FIXED TO THE ANTERIOR VAGINAL WALL AT POINT AA USING BLUE DYE AS A LANDMARK. THE BLADDER-VAGINAL SEPTUM WAS PLICATED BILATERALLY WITH STRATAFIX SPIRAL PDS PLUS (ETHICON INC., CINCINNATI, OH, USA) TO REINFORCE THE ARL (FIGURE 2B). REPORTED COMPLICATIONS INCLUDE: 2-0 ETHIBOND THREAD (ETHICON) PELVIC INFLAMMATORY DISEASE (CLAVIEN¿DINDO GRADE GREATER THAN OR EQUAL TO 2) (N=5) TREATMENT: SUCCESSFULLY TREATED WITH INTRAVENOUS ANTIBIOTICS DE NOVO STRESS URINARY INCONTINENCE (SUI) (N=1) TREATMENT: NOT REPORTED. RECURRENCE PRESENTING WITH CYSTOCELES (N=7) TREATMENT: TWO SACROSPINOUS LIGAMENT FIXATIONS, TWO COLPOCLEISIS PROCEDURES, ONE ANTERIOR COLPORRHAPHY AND TWO WERE MANAGED CONSERVATIVELY WITH PESSARY INSERTION. STRATAFIX SPIRAL PDS PLUS (ETHICON) PELVIC INFLAMMATORY DISEASE (CLAVIEN¿DINDO GRADE GREATER THAN OR EQUAL TO 2) (N=5) TREATMENT: SUCCESSFULLY TREATED WITH INTRAVENOUS ANTIBIOTICS DE NOVO STRESS URINARY INCONTINENCE (SUI) (N=1) TREATMENT: NOT REPORTED. RECURRENCE PRESENTING WITH CYSTOCELES (N=7) TREATMENT: TWO SACROSPINOUS LIGAMENT FIXATIONS, TWO COLPOCLEISIS PROCEDURES, ONE ANTERIOR COLPORRHAPHY AND TWO WERE MANAGED CONSERVATIVELY WITH PESSARY INSERTION. IN CONCLUSION, THIS IS THE FIRST STUDY TO REPORT NON-MESH RSC USING AN AUTOLOGOUS ARL GRAFT. THE ABSENCE OF A SYNTHETIC MESH ENABLES TOTAL HYSTERECTOMY AND ELIMINATES THE INVASIVENESS ASSOCIATED WITH FASCIA LATA HARVESTING. THE SHORT-TERM OUTCOMES WERE COMPARABLE TO THOSE OF MESH-BASED RSC, AND CONTINUED CASE ACCUMULATION AND LONG-TERM FOLLOW-UP ARE WARRANTED TO FURTHER VALIDATE THIS TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556063 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention