BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 15682760 · Received October 27, 2022

    Report

    Report Number
    2210968-2022-08852
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    May 5, 2022
    Report Date
    October 27, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: INTERNATIONAL JOURNAL OF SURGERY OPEN 43 (2022) 100481. HTTPS://DOI.ORG/10.1016/J.IJSO.2022.100481.

    Description of Event or Problem · 0

    TITLE: ROBOT-ASSISTED DONOR NEPHRECTOMY: INITIAL RESULTS AND COMPARISON WITH THE HAND-ASSISTED LAPAROSCOPIC TECHNIQUE. A RETROSPECTIVE STUDY. THE AIM OF THIS STUDY IS TO EVALUATE FEASIBILITY AND SAFETY OF ROBOTIC-ASSISTED DONOR NEPHRECTOMY (RADN) AS COMPARED WITH THE HAND-ASSISTED LAPAROSCOPIC TECHNIQUE (HALDN). THIS IS A SINGLE CENTER RETROSPECTIVE OBSERVATIONAL STUDY PERFORMED IN THE UNIVERSITY HOSPITAL. THE FIRST RADN IN OUR CENTER WAS PERFORMED IN MARCH 2019, AND THE RADN GROUP CONSIST OF 83 CONSECUTIVE PROCEDURES UNTIL MARCH 2021. THE RADN WERE COMPARED WITH 103 CONSECUTIVE HALDN THAT WERE PERFORMED BETWEEN MARCH 2017 AND MARCH 2021. HARMONIC SHEARS AND PDS 2-0 SUTURE WAS USED. REPORTED COMPLICATIONS INCLUDED IN THE RADN THERE WAS ONE STAPLER DYSFUNCTION ON TRANSECTING THE RENAL ARTERY, WOUND HERNIAS OCCURRED, CLAVIEN-DINDO GRADE II AND CLAVIEN-DINDO GRADE IIIB IN CONCLUSION RADN IS A SAFE AND EFFECTIVE METHOD FOR DONOR NEPHRECTOMY AS IT HAS COMPARABLE SURGICAL OUTCOMES TO ESTABLISHED STANDARD OF CARE. OUR EXPERIENCE HAS SHOWN THAT THE DA VINCI SURGICAL SYSTEM CAN BE ADOPTED RAPIDLY AND SAFELY IN TRANSPLANT SURGERY. THE COMING PERIODS MULTIPLE SURGICAL ROBOTS WILL BE AVAILABLE ON THE MARKET AND WE WILL PROBABLY PROCEED TO ROBOTIC-ASSISTED SURGERY AS THE NEXT LEVEL OF LAPAROSCOPIC SURGERY. CONTINUOUS EVALUATION OF THESE NEW ROBOTIC TECHNOLOGIES WILL ASSIST IN OPTIMIZING ITS FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511007 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention