BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP*ENDO

    MDR report key: 10762179 · Received October 30, 2020

    Report

    Report Number
    3005075853-2020-05635
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    January 1, 2018
    Report Date
    October 6, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT: PUBLICATION YEAR FOR THE JOURNAL ARTICLE IS 2018. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THIS ARTICLE? IF YES, PLEASE EXPLAIN. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE, TITLE: OPEN MANAGEMENT OF THE RENAL VEIN IS A SAFE MODIFICATION IN RIGHT-SIDED LAPAROSCOPIC LIVING DONOR NEPHRECTOMY TO MAXIMIZE GRAFT VEIN LENGTH AUTHOR: C. MARGREITER, M. GUMMERER, V. GALLOTTA, S. SCHEIDL, D. ÖFNER, K. KIENZL-WAGNER, H.T. MAIER, R. OBERHUBER, R. MARGREITER, AND S. SCHNEEBERGER. CITATION: TRANSPLANTATION PROCEEDINGS, 50, 3199E3203 (2018). DOI: HTTPS://DOI.ORG/10.1016/J.TRANSPROCEED.2018.06.005. THE GOAL OF THIS STUDY WAS TO DEMONSTRATE THE FEASIBILITY OF A HYBRID TECHNIQUE USING A SATINSKY CLAMP IN RIGHT-SIDED LIVING DONOR NEPHRECTOMY TO OBTAIN MAXIMAL RENAL VEIN AND TO COMPARE THE OUTCOME WITH STANDARD LEFT-SIDED LAPAROSCOPIC DONOR NEPHRECTOMIES. BETWEEN 2005 AND 2013, 77 PATIENTS UNDERWENT A LEFT (GROUP L) AND 54 A RIGHT (GROUP R) LIVING DONOR NEPHRECTOMY. INFERIORLY, THE URETER WAS CLOSED WITH ONE LARGE TITANIUM CLIP (ETHICON). THE VENOTOMY WAS THEN CLOSED WITH A RUNNING 4-0 PROLENE SUTURE (ETHICON) IN GROUP R. IN THE EARLY POSTOPERATIVE PERIOD, A LAPAROTOMY HAD TO BE PERFORMED DUE TO A SMALL BOWEL OBSTRUCTION IN A R-LDN PATIENT AT POSTOPERATIVE DAY 7 (N=1). OPEN MANAGEMENT OF THE RENAL VEIN IS A SAFE ALTERNATIVE IN LAPAROSCOPIC RIGHT-SIDED DONOR NEPHRECTOMY AND ENSURES MAXIMAL LENGTH OF THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231487 LIGACLIP*ENDO CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention