BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 9981204 · Received April 21, 2020

    Report

    Report Number
    2210968-2020-03270
    Event Type
    Injury
    Date Received
    April 21, 2020
    Report Date
    April 1, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GEA
    PMA / PMN Number
    K925914
    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. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ETHICON (ENDOLOOP SUTURE) PRODUCTS 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 (ENDOLOOP SUTURE) PRODUCTS USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: UROLOGY. 2018; 121: 182-188. DOI: HTTPS://DOI.ORG/10.1016/J.UROLOGY.2018.08.023. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: PRELIMINARY KIDNEY PARENCHYMAL LIGATION USING ENDOLOOP LIGATURES¿A SIMPLE METHOD TO ACHIEVE A TRIFECTAIN LAPAROSCOPIC PARTIAL NEPHRECTOMY WITHOUT HILAR CLAMPING FOR POLAR COMPLEX TUMORS". AUTHORS: YOSHINOBU KOMAI, NAOTO GOTOHDA, NOBUAKI MATSUBARA, HAYATO TAKEDA, TAKESHI YUASA, MASAHARU INOUE, SHINYA YAMAMOTO, JUNJI YONESE. CITATION: UROLOGY. 2018; 121: 182-188. DOI: HTTPS://DOI.ORG/10.1016/J.UROLOGY.2018.08.023. THE OBJECTIVES OF THE STUDY WAS TO DESCRIBE A NOVEL AND SIMPLE TECHNIQUE OF PRELIMINARY KIDNEY PARENCHYMAL LIGATION USING ENDOLOOP LIGATURES (ETHICON) DURING THE LAPAROSCOPIC PARTIAL NEPHRECTOMY (PN) WITHOUT HILAR CLAMPING FOR POLAR COMPLEX TUMOR CASES. THE SUBJECTS WERE 17 PATIENTS WHO HAD RENAL MASS LOCATED IN THE POLE OF THE KIDNEY WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, TWO OR THREE ENDOLOOP LIGATURES (ETHICON) WERE PLACED MORE DISTALLY, AND TIGHTENED MORE FIRMLY, THAN THE FIRST WITH THE INTENT THAT BOTH THE URINARY TRACT AND VASCULATURE WOULD BE FIRMLY LIGATED AS A BUNDLE. DURING THIS STEP, THE CHEESE-WIRE PHENOMENON PROVOKED BY ROBUST LIGATION, WHICH IS THE PROCESS OF USING A SUTURE TO CUT THROUGH THE KIDNEY PARENCHYMA, SHOULD BE ACHIEVED BECAUSE IT CAN RESULT IN EFFECTIVE PARENCHYMAL DISSECTION WITHOUT DAMAGING THE TUMOR CAPSULE. REPORTED COMPLICATIONS INCLUDED URINE LEAK (N-1) BUT QUICKLY RECTIFIED BY RETROGRADE PLACEMENT OF A URETERAL STENT, AND ON POD 17 THE DRAIN WAS REMOVED. THE CURRENT PRELIMINARY PARENCHYMAL LIGATION METHOD HELPED SURGEONS ACHIEVE THE TRIFECTA IN PATIENTS WITH POLAR COMPLEX MASSES TREATED WITH LAPAROSCOPIC PN. THE CURRENT TECHNIQUE CAN ALSO PROVIDE SURGEONS WITH A BLOODLESS OPERATIVE FIELD EVEN DURING PN WITHOUT HILAR CLAMPING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445092 ENDOLOOP LIGATURE UNKNOWN PRODUCT LAPROSCOPE, GENERAL & PLASTIC SURGERY GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention