BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 8204598 · Received December 28, 2018

    Report

    Report Number
    2210968-2018-78083
    Event Type
    Injury
    Date Received
    December 28, 2018
    Report Date
    December 10, 2018
    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. CITATION: SURG ENDOSC (2004) 18: 749¿750; DOI: 10.1007/S00464-003-9156-Z. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC APPENDECTOMY USING ENDOLOOPS". AUTHOR(S): G. BELDI, K. MUGGLI, C. HELBLING, R. SCHLUMPF. CITATION: SURG ENDOSC (2004) 18: 749¿750; DOI: 10.1007/S00464-003-9156-Z. THIS PROSPECTIVE, RANDOMIZED CLINICAL TRIAL AIMED TO EVALUATE THE NUMBER OF LOOPS NEEDED FOR LAPAROSCOPIC APPENDECTOMY. BETWEEN JUL1999 AND NOV2000, 208 PATIENTS WITH SUSPECTED APPENDICITIS UNDERWENT LAPAROSCOPIC APPENDECTOMY IN WHICH 109 HAD ONE LOOP (GROUP 1) AND 99 HAD TWO LOOPS (GROUP 2). IN THE PROCEDURE, ONE OR TWO ENDOLOOPS WAS PLACED NEAR TO THE APPENDIX BASE AND ADDITIONAL ENDOLOOP WAS PLACED 6-12MM DISTALLY. IN GROUP 1, COMPLICATION INCLUDED INTRAABDOMINAL ABSCESS (N=5) TREATED WITH REOPERATION (N=1) AND PERCUTANEOUS DRAINAGE (N=2). IN GROUP 2, COMPLICATIONS INCLUDED ABSCESS (N=4) TREATED WITH SURGICAL DRAINAGE AND PERCUTANEOUS DRAINAGE (N=2) OF WHICH ONE HAD PROLONGED DRAINAGE THROUGH A PERCUTANEOUS DRAIN FOR 10 DAYS. A POTENTIALLY HIGHER RATE OF STUMP INSUFFICIENCY IN GROUP 1 DUE TO AN INSUFFICIENT CLOSURE OF THE BASE OF THE APPENDIX WAS NOT OBSERVED. ANOTHER REASON FOR SEPTIC COMPLICATIONS AFTER APPENDECTOMY COULD BE AN INFECTED HEMATOMA. THE SIGNIFICANCE OF INSUFFICIENT HEMOSTASIS THAT, IN COMBINATION WITH A LOCALIZED BACTERIAL PERITONITIS, CAUSES ABSCESS FORMATION REMAINS UNKNOWN. IN CONCLUSION, THE PRESENT STUDY SHOWS THAT THE TREATMENT OF THE APPENDIX BASE CAN BE SAFELY DONE WITH THE USE OF ONLY ONE ENDOLOOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042895 ENDOLOOP LIGATURE UNKNOWN PRODUCT CANNULA, SURGICAL, GENERAL GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention