BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 8207977 · Received January 2, 2019

    Report

    Report Number
    3005075853-2019-15429
    Event Type
    Injury
    Date Received
    January 2, 2019
    Report Date
    December 5, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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. CAN YOU PLEASE CONFIRM THE SPECIFIC NUMBER OF PATIENTS IN EACH OF THE GROUPS? THIS IS IN REFERENCE TO BOTH PHASE I AND PHASE II OF THE STUDY. IN ADDITION, CAN YOU PLEASE PROVIDE THE SPECIFIC PRODUCT CODE(S) OF ALL ETS ARTICULATING LINEAR CUTTERS INVOLVED IN THE STUDY?

    Description of Event or Problem · 1

    IT WAS REPORTED IN 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
    1742 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention