BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 8200108 · Received December 27, 2018

    Report

    Report Number
    2210968-2018-78048
    Event Type
    Injury
    Date Received
    December 27, 2018
    Report Date
    December 5, 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. 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 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 USED IN THIS PROCEDURE? CITATION: BMC SURGERY. 2017; 17: 80. DOI: 10.1186/S12893-017-0277-Z. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "INTENDED COST REDUCTION IN LAPAROSCOPIC APPENDECTOMY BY INTRODUCING THE ENDOLOOP: A SINGLE CENTER EXPERIENCE." AUTHORS: MATTHIAS MEHDORN, OLAF SCHÜRMANN, H. MAXIMILIAN MEHDORN, INES GOCKEL. CITATION: BMC SURGERY. 2017; 17: 80. DOI: 10.1186/S12893-017-0277-Z. COST REDUCTION MEASURES IN MEDICINE ARE GAINING GREATER IMPORTANCE NOWADAYS, ESPECIALLY IN HIGH VOLUME PROCEDURES SUCH AS LAPAROSCOPIC APPENDECTOMY (LAE). THE GOAL OF THIS STUDY WAS TO RETROSPECTIVELY EVALUATE POSSIBLE COST REDUCTION DUE TO INCREASED USE OF ENDOLOOP IN LAE IN OUR GENERAL SURGERY DEPARTMENT OF A TERTIARY REFERRAL UNIVERSITY HOSPITAL. THE AUTHORS PREVIOUSLY USED THE STAPLER FOR APPENDIX DISSECTION IN LAE AS THE LOCAL PROTOCOL BUT INTRODUCED THE ENDOLOOP (ETHICON) AS STANDARD METHOD IN 2015 TO REDUCE INTRAOPERATIVE COSTS. THE AUTHORS CONDUCTED A RETROSPECTIVE ANALYSIS OF 177 PATIENTS (77 MALE AND 100 FEMALE PATIENTS; AGE: 27.8 ± 15.5 YEARS) WHO UNDERWENT LAE BETWEEN JUNE 2014 AND OCTOBER 2015 IN THE DEPARTMENT. IN PHASE I, THE STAPLER WAS THE STANDARD APPROACH; IN PHASE II THE ENDOLOOP PDS II 0 SUTURE (ETHICON) WAS THE STANDARD DEVICE BUT IF AN ADVANCED APPENDICITIS WITH INFLAMMATION OF THE PROXIMAL APPENDIX, THE CECAL POLE OR PERFORATION WAS ENCOUNTERED, RESECTION WAS PERFORMED WITH THE STAPLER. THE AUTHORS USED AN ETS ARTICULATING LINEAR CUTTER (ETHICON). FOR PHASE I AND PHASE II COHORT, REPORTED COMPLICATIONS INCLUDED SUPERFICIAL WOUND SITE INFECTION (N-1), PERSISTENT INTRAABDOMINAL ABSCESS WHICH REQUIRED REINTERVENTION, "INTRAABDOMMINAL" ABSCESS FORMATION, PERITYPHLITIC ABSCESS WHICH WERE TREATED WITH POST-OPERATIVE ABDOMINAL LAVAGE VIA INTRA-OPERATIVELY PLACED DRAINAGE CATHETERS AND INTRAVENOUS ANTIBIOTICS, AND SEVERE SEPSIS (N-1) AND CONSEQUENTLY FULLY RECOVERED. ALTHOUGH THE ENDOLOOP (ETHICON) IS A PRACTICAL AND CHEAP DEVICE FOR RESECTING THE APPENDIX IN LAPAROSCOPIC APPENDECTOMY, THE ¿TRUE¿ ECONOMIC BENEFIT OF THE ENDOLOOP AS STANDARD METHOD FOR LAE IS NOT AS HIGH AS EXPECTED A PRIORITY WHEN REGARDING COSTS OF EACH DEVICE. IN THE SERIES, COSTS BY PROLONGED DO NEGATED SOME OF THE EXPECTED SAVINGS BY ENDOLOOP FOR VARIOUS POSSIBLE REASONS, E.G. SURGEON¿S LEARNING CURVES, SURGEONS AT AN EARLY STAGE OF TRAINING. GROWING EXPERIENCE WITH THE ENDOLOOP MIGHT REVEAL MORE PRONOUNCED COST-REDUCTION POSSIBILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038741 ENDOLOOP LIGATURE UNKNOWN PRODUCT CANNULA, SURGICAL, GENERAL GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention