BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12457539 · Received September 10, 2021

    Report

    Report Number
    2210968-2021-08337
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    August 25, 2020
    Report Date
    August 23, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. ATTEMPTS ARE BEING MADE TO CLARIFY 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 AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE AND VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS OF NON-IDENTIFIED CASES (N=8 POSTOPERATIVE FEVER, N=8 PAIN AND N=4 POSTOPERATIVE INFECTION) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (ETHIBOND SUTURE AND VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS OF FOLLOWING PATIENTS: A (B)(6) YEARS OLD (HEMATOMA), A (B)(6) YEARS OLD (LYMPHOCELE), A (B)(6) YEARS OLD (FEVER, ABSCESS), A (B)(6) YEARS OLD PATIENT #(B)(6) (VAGINAL CUFF INSUFFICIENCY); A (B)(6) YEARS OLD (VAGINAL DISCHARGE, VAGINAL CUFF INSUFFICIENCY) AND A (B)(6) YEARS OLD PATIENT #(B)(6) (HEMOPERITONEUM)? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ETHIBOND SUTURE AND VICRYL SUTURE) USED FOR ALL ABOVE CASES IN THIS STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR NON-IDENTIFIED CASES (N=8 POSTOPERATIVE FEVER, N=8 PAIN AND N=4 POSTOPERATIVE INFECTION)? WERE ANY MEDICAL/SURGICAL INTERVENTIONS PERFORMED TO TREAT POST-OP COMPLICATIONS FOR N=8 POSTOPERATIVE FEVER, N=8 PAIN, N=4 POSTOPERATIVE INFECTION AND FOR A (B)(6) YEARS OLD PATIENT WITH POST-OP LYMPHOCELE? IF SO, PLEASE SPECIFY. WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: ARCHIVES OF GYNECOLOGY AND OBSTETRICS (2020) 302:1381¿1388. HTTPS://DOI.ORG/10.1007/S00404-020-05751-8. EVENTS WERE SUBMITTED VIA 2210968-2021-08333, 2210968-2021-08334, 2210968-2021-08335, 2210968-2021-08336, 2210968-2021-08338 AND 2210968-2021-08339.

    Description of Event or Problem · 1

    TITLE: IMPLEMENTATION OF ROBOTIC GYNECOLOGICAL SURGERY IN A GERMAN UNIVERSITY HOSPITAL: PATIENT SAFETY AFTER 110 PROCEDURES. AUTHOR/S: DIMITRIOS BALAFOUTAS · ACHIM WÖCKEL · CHRISTINE WULFF · RALF JOUKHADAR. CITATION: ARCHIVES OF GYNECOLOGY AND OBSTETRICS (2020) 302:1381¿1388. HTTPS://DOI.ORG/10.1007/S00404-020-05751-8. THIS STUDY AIMS TO DESCRIBE THE EXPERIENCE IN IMPLEMENTING ROBOTIC SURGERY IN A GERMAN UNIVERSITY HOSPITAL FOCUSING ON PATIENT SAFETY AFTER 110 PROCEDURES. A TOTAL OF 110 CONSECUTIVE ROBOTIC PROCEDURES PERFORMED IN THE UNIVERSITY HOSPITAL OF WÜRZBURG BETWEEN JUNE 2017 AND SEPTEMBER 2019 WERE INCLUDED. DURING THIS TIME, 37 PATIENTS WERE TREATED FOR BENIGN GENERAL GYNECOLOGICAL CONDITIONS, 27 PATIENTS FOR GYNECOLOGICAL MALIGNANCIES, AND 46 PATIENTS FOR UROGYNECOLOGICAL CONDITIONS. THE MEAN PATIENT AGE WAS 55 YEARS, WHILE PROLAPSE PATIENTS TENDED TO BE OLDER. THE MOST WIDELY USED DAVINCI INSTRUMENTS WERE THE HOT SHEARS¿ (MONOPOLAR CURVED SCISSORS), THE FENESTRATED BIPOLAR FORCEPS, AND THE MEGA SUTURECUT¿ NEEDLE DRIVER. WHEN TRANSVAGINAL TISSUE EXTRACTION WAS NOT POSSIBLE, THE ALEXIS CONTAINED EXTRACTION SYSTEM (APPLIED MEDICAL, RANCHO SANTA MARGARITA, CALIFORNIA, UNITED STATES) WAS USED. WE PERFORMED THE CLOSURE OF THE VAGINAL CUFF IN ALL PROCEDURES INVOLVING A TOTAL HYSTERECTOMY WITH VICRYL INTERRUPTED SUTURES (POLYGLACTIN 910 COATED VICRYL SUTURE; ETHICON/JOHNSON & JOHNSON, NEW BRUNSWICK, UNITED STATES). THE MESH MATERIAL USED IN ROBOTIC SACROCOLPOPEXY WAS THE DYNAMESH TAILORED IMPLANT (PR VISIBLE OR PRS VISIBLE) MADE UP OF POLYVINYLIDENFLUORID (PVDF), (FEG TEXTILTECHNIK MBH, AACHEN, GERMANY), WHICH WAS FIXED WITH ETHIBOND SUTURES (ETHICON/JOHNSON & JOHNSON, SOMERVILLE, NEW JERSEY, UNITED STATES). NO INTRAOPERATIVE COMPLICATIONS OCCURRED, AS ALL COMPLICATIONS WERE DIAGNOSED POSTOPERATIVELY, EITHER DURING HOSPITAL STAY OR AFTER PATIENT DISCHARGE. WHILE 90 (81.8%) OF THE PROCEDURES WERE COMPLETED WITHOUT A COMPLICATION, THERE WAS NEED FOR A SURGICAL REVISION UNDER GENERAL ANESTHESIA IN SIX (5.5%) PATIENTS. THE REMAINING 12.7% OF THE PATIENTS EXPERIENCED GRADE I¿IIIA COMPLICATIONS. EVALUATED PATIENT SAFETY THROUGH STANDARDIZED ASSESSMENT OF INTRA- AND POSTOPERATIVE COMPLICATIONS, WHICH WERE CATEGORIZED ACCORDING TO THE CLAVIEN¿DINDO CLASSIFICATION. THE (B)(6) YEAR-OLD PATIENT ADMITTED TO THE HOSPITAL ON THE 7TH DAY AFTER SURGERY WITH FEVER AND DIAGNOSED WITH SMALL WOUND SITE ABSCESS AT THE VAGINAL CUFF WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND LOCAL DRAINING OF THE ABSCESS TRANSVAGINALLY UNDER LOCAL ANESTHESIA. REPORTED ADVERSE EVENTS: A (B)(6) YEAR-OLD PATIENT WHO UNDERWENT TOTAL HYSTERECTOMY AND SALPINGO-OOPHORECTOMY EXPERIENCED FEVER AND SMALL WOUND SITE ABSCESS AT THE VAGINAL CUFF. IN CONCLUSION, STRUCTURED PROCEEDINGS MAKE IT FEASIBLE TO RAPIDLY IMPLEMENT ROBOTIC SURGERY IN A GERMAN UNIVERSITY HOSPITAL WITHOUT COMPROMISING PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350296 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention