BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EB EXC GRN 4X30IN 5 S/A V-37

    MDR report key: 20335633 · Received September 30, 2024

    Report

    Report Number
    2210968-2024-10404
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    January 1, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    UDI-DI
    10705031046290
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. AN ATTEMPT HAS BEEN 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES 2023; 27: 6215-6222.

    Description of Event or Problem · 0

    TITLE: CLINICAL EFFICACY OF MODIFIED SACRAL FIXATION UNDER LEONARDO DA VINCI ROBOT LAPAROSCOPY FOR PELVIC ORGAN PROLAPSE. THE AIM OF THIS STUDY WAS TO ANALYZE THE CLINICAL EFFICACY OF MODIFIED SACRAL FIXATION UNDER LEONARDO DA VINCI ROBOT LAPAROSCOPY FOR PELVIC ORGAN PROLAPSE (POP). BETWEEN (B)(6)2020 AND (B)(6) 2021, A TOTAL OF (B)(4) PATIENTS WITH PELVIC ORGAN PROLAPSE (POP) WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO GROUP A (LAPAROSCOPIC Y-MESH, (B)(4)), GROUP B (LAPAROSCOPIC SACROVAGINAL FIXATION, (B)(4)), AND GROUP C (DA VINCI ROBOTIC SACRAL FIXATION, (B)(4)). THE SUBJECTS OF THE THREE GROUPS WERE WOMEN. THE AVERAGE AGE, AVERAGE PROLAPSE TIME, AND AVERAGE DELIVERIES WERE (63.16 ± 11.85) YEARS OLD, (4.56 ± 1.28) YEARS, AND (2.56 ± 1.85) TIMES IN GROUP A, RESPECTIVELY, (62.89 ± 10.74) YEARS OLD, (4.39 ± 1.18) YEARS AND (2.46 ± 1.74) TIMES IN GROUP B, AND (62.78 ± 12.06) YEARS OLD, (4.45 ± 1.12) YEARS, (2.39 ± 1.12) TIMES IN GROUP C. T PATIENTS IN GROUP A WERE TREATED WITH LAPAROSCOPIC Y-SHAPED MESH (BRAND: JOHNSON & JOHNSON, PURCHASED IN (B)(6) MEDICAL EQUIPMENT SALES CO., LTD., (B)(6), CHINA); BOTH SIDES WERE INTERRUPTED SUTURED ON THE MAIN SACRAL LIGAMENT COMPLEX, AND THE OTHER END OF THE MESH WAS INTERRUPTED SUTURE FIXED TO THE ANTERIOR SACRAL LONGITUDINAL LIGAMENT IN FRONT OF THE S1 VERTEBRAL BODY BY USING THE NON-ABSORBABLE SUTURE OF AIXIBANG MB66 (MB66G, JOHNSON & JOHNSON, (B)(6) MEDICAL EQUIPMENT CO., LTD.,(B)(6), CHINA). THE PATIENTS IN GROUP B WERE TREATED WITH MODIFIED MESH SACRAL FIXATION USING TWO BOOT-SHAPED MESH (JOHNSON & JOHNSON, PURCHASED IN (B)(6) MEDICAL EQUIPMENT SALES CO., LTD., (B)(6), CHINA). REPORTED COMPLICATIONS IN GROUP A INCLUDE HEMORRHAGIC (N=3), INFECTION (N=2), MESH EXPOSURE (N=3), AND RECURRENCE (N=2). IN GROUP B INCLUDE HEMORRHAGIC (N=1) AND MESH EXPOSURE (N=1). IN CONCLUSION, THE EFFICACY OF MODIFIED SACRAL FIXATION UNDER LEONARDO DA VINCI ROBOT LAPAROSCOPY FOR POP WAS COMPARABLE TO THAT OF LAPAROSCOPIC Y-MESH TREATMENT AND LAPAROSCOPIC SACRAL VAGINAL FIXATION. HOWEVER, DA VINCI¿S ROBOTIC SACRAL FIXATION HAD THE ADVANTAGES OF LESS INTRAOPERATIVE BLEEDING AND FASTER POSTOPERATIVE RECOVERY, WHICH HELPED PATIENTS RECOVER QUICKLY AND IMPROVED THEIR QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602834 EB EXC GRN 4X30IN 5 S/A V-37 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC. 10705031046290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other