BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19058203 · Received April 8, 2024

    Report

    Report Number
    2210968-2024-03970
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-03970 AND 2210968-2024-03971. CITATIONS : JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES VOLUME 34(1).1-6. HTTPS://DOI.ORG/10.1089/LAP.2023.0337.

    Description of Event or Problem · 0

    TITLE : EVALUATING THE ONCOLOGICAL AND FUNCTIONAL OUTCOMES IN 167 PATIENTS UNDERGOING LAPAROSCOPIC RADICAL PROSTATECTOMY: COULD LAPAROSCOPY STILL BE A VIABLE OPTION IN SUITABLE PATIENTS. THE AIM OF THIS STUDY WAS TO EVALUATE THE ONCOLOGICAL AND FUNCTIONAL OUTCOMES OF 167 PATIENTS WHO UNDERWENT LAPAROSCOPIC RADICAL PROSTATECTOMY (LRP). THE RETROSPECTIVE STUDY INCLUDED 167 PATIENTS WHO WERE TREATED WITH LRP DUE TO CLINICALLY LOCALIZED PROSTATE CANCER BETWEEN (B)(6) 2007 AND (B)(6) 2012. THE ENDOPELVIC FASCIA WAS BILATERALLY INCISED AND THEN THE PLEXUS WAS SECURED BY INSERTING TWO CONSECUTIVE POLYGLACTIN SUTURES (VICRYL MH 2/0) BETWEEN SANTORINI¿S VENOUS PLEXUS AND URETHRA, FOLLOWED BY THE INSERTION OF AN ENDOSCOPIC SUTURE (VICRYL SH 2/0) IN THE PROSTATE BASE TO PREVENT BACKFLOW. THE VESICO-URETHRAL ANASTOMOSIS WAS PERFORMED USING THE VAN VELTHOVEN RUNNING STITCH TECHNIQUE WITH TWO 3/0 PDS RB-1 NEEDLES IN DIFFERENT COLORS. THE REPORTED COMPLICATIONS INCLUDED ORCHITIS (N=2), HERPES SEPSIS (N=1), BLADDER NECK CONTRACTURE (N=4), BLADDER PERFORATION (N=1),AND CONTINUOUS INCONTINENCE (N=7). IN CONCLUSION, LRP IS AN ACCEPTABLE METHOD IN LOCALIZED PROSTATE CANCER DUE TO ITS PERIOPERATIVE AND EARLY POSTOPERATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96510 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention