BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22346488 · Received June 27, 2025

    Report

    Report Number
    2210968-2025-07553
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    February 12, 2024
    Report Date
    June 27, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: UROLOGIA. 2024 MAY;91(2):357-363. DOI: 10.1177/03915603241229144. EPUB 2024 FEB 12. PMID: 38345047. HTTPS://DOI.ORG/10.1177/03915603241229144.

    Description of Event or Problem · 0

    ROBOT-ASSISTED URETERIC RECONSTRUCTIVE SURGERIES FOR BENIGN DISEASES: INITIAL SINGLE-CENTER EXPERIENCE WITH POINT OF TECHNIQUE. THE AIM OF THIS STUDY IS TO PRESENT OUR INITIAL EXPERIENCE WITH ROBOT-ASSISTED RECONSTRUCTIVE SURGERIES WITH THE DA VINCI XI ROBOTIC SYSTEM FOR BENIGN URETERIC PATHOLOGIES. BETWEEN APRIL 2018 TO NOVEMBER 2022, A TOTAL OF 34 PATIENTS (GENDER : MALE 25 (73.52), FEMALE 9 (26.47); AGE E (YEARS) (MEAN)±SD : MALES 40±15.1, FEMALES 32±20.6) WERE INCLUDED IN THE STUDY. THE ETHICON DEVICE WERE USED IN : THE URETER WAS SPATULATED AND ANDERSON HYNES DISMEMBERED PYELOPLASTY WAS PERFORMED WITH VICRYL (ETHICON) 4-0 ROUNDBODIED SUTURES OVER A DOUBLE J (DJ) STENT; VICRYL 3-0 SUTURE WAS PLACED THROUGH THE TENDON IN A LONGITUDINAL FASHION AND THROUGH THE SUPERIOR AND IPSILATERAL WALL OF THE BLADDER IN A FIGURE-OF-EIGHT FASHION; THE DETRUSOR MUSCLE WAS BUTTRESSED OVER THE URETER FORMING A SUBMUCOSAL TUNNEL USING 3-0 VICRYL SUTURES BY THE LICHGREGOIR TECHNIQUE; AND A URETERIC STENT WAS PLACED, THE REMAINING BLADDER FLAP WAS TUBULARIZED AND THE BLADDER DEFECT WAS REPAIRED WITH A 3-0 VICRYL SUTURE. REPORTED COMPLICATIONS ARE URINARY TRACT INFECTION (N=5). IN CONCLUSION, ROBOTIC PLATFORMS HAVE PROVIDED AN IMPETUS FOR INNOVATION IN SURGICAL TECHNIQUES WHILE KEEPING IN MIND PATIENT¿S SAFETY AND POSTOPERATIVE OUTCOMES. OUR INITIAL EXPERIENCE IN AFOREMENTIONED ROBOT ASSISTED SURGERIES WITH DA VINCI XI SYSTEM IMPARTED EXCELLENT OUTCOMES WITHOUT MAJOR COMPLICATIONS. FOR A SURGEON WITHOUT EXTENSIVE LAPAROSCOPIC EXPERIENCE, ROBOTS PROVIDE A COMFORTABLE ERGONOMIC PLATFORM FOR WORKING IN THE DEEP PELVIS AND IS A GREAT OPTION FOR PATIENTS UNDERGOING VARIOUS UROLOGIC RECONSTRUCTIVE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938540 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention