BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9537869 · Received January 2, 2020

    Report

    Report Number
    2210968-2019-91296
    Event Type
    Injury
    Date Received
    January 2, 2020
    Report Date
    December 5, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: INT J MED ROBOTICS COMPUT ASSIST SURG. 2019;E2038; DOI: HTTPS://DOI.ORG/10.1002/RCS.2038 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: COMPARISON BETWEEN THE VASCULAR CONTROL TECHNIQUE AND CONVENTIONAL TECHNIQUE FOR REDUCING OPERATIVE BLOOD LOSS DURING ROBOT-ASSISTED MYOMECTOMY". AUTHOR/S:TAEJONG SONG, YOUNG GI HAN, JI-HEE SUNG. CITATION: INT J MED ROBOTICS COMPUT ASSIST SURG. 2019;E2038; DOI: HTTPS://DOI.ORG/10.1002/RCS.2038. THIS RETROSPECTIVE STUDY AIMED TO COMPARE THE SURGICAL OUTCOMES AND MORBIDITY OF THE VASCULAR CONTROL TECHNIQUE IN ROBOTIC MYOMECTOMY WITH THE CONVENTIONAL TECHNIQUE. BETWEEN JANUARY 2017 AND MARCH 2019, 32 CONSECUTIVE PATIENTS (AGE RANGE=39.3 ± 4.7 YEARS; BMI=22.6 ± 3.2 KG /M^2) UNDERWENT MYOMECTOMY USING VASCULAR CONTROL TECHNIQUE (PRACTICE CHANGE COHORT) AND COMPARED RETROSPECTIVELY WITH 32 CONSECUTIVE PATIENTS (AGE RANGE=38.6 ± 4.1 YEARS; BMI=22.4 ± 3.4 KG/M^2) WHO UNDERWENT ROBOTIC MYOMECTOMY WITHOUT THE VASCULAR CONTROL TECHNIQUE (HISTORICAL COHORT) BETWEEN APRIL 2015 AND DECEMBER 2016. DURING THE PROCEDURE, THE UMBILICAL FASCIA WAS CLOSED BY RUNNING SUTURE WITH A 1-0 VICRYL (ETHICON). REPORTED COMPLICATION INCLUDED UMBILICAL WOUND INFECTION (N=1) TREATED WITH ORAL ANTIBIOTICS WITHOUT SURGICAL INTERVENTION IN THE PRACTICE CHANGE COHORT. IN CONCLUSION, THE VASCULAR CONTROL TECHNIQUE IN ROBOTIC MYOMECTOMY APPEARS TO BE EFFECTIVE AND SAFE IN THE MANAGEMENT OF SELECTIVE PATIENTS WITH SYMPTOMATIC MYOMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention