BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM ARTICNG LNR CUTR/GRN RLD

    MDR report key: 8208219 · Received January 2, 2019

    Report

    Report Number
    3005075853-2019-15431
    Event Type
    Injury
    Date Received
    January 2, 2019
    Report Date
    December 5, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001065
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH JOURNAL ARTICLE TITLE: ANALYSIS OF ENDOLOOPS AND ENDOSTAPLES FOR CLOSING THE APPENDICEAL STUMP DURING LAPAROSCOPIC APPENDECTOMY AUTHORS: MISLAV RAKIC, MIRO JUKIC, ZENON POGORELIC, IVANA MRKLIC, ROBERT KLICEK, NIKICA DRUZIJANIC, ZDRAVKO PERKO AND LEONARDO PATRLJ CITATION: SURG TODAY (2014) 44:1716¿1722; DOI 10.1007/S00595-013-0818-8; PUBLISHED ONLINE: 12 DECEMBER 2013. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICIENCY OF EACH TECHNIQUE BY FOCUSING ON THE INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS VERSUS COST. BETWEEN JUNE 2011 AND JUNE 2013, A TOTAL OF 333 PATIENTS (188 MALES AND 155 FEMALES WITH AGE RANGE FROM 5 TO 80 YEARS OLD) WHO UNDERWENT LAPAROSCOPIC APPENDECTOMY (LA) WERE INCLUDED. THE DATA WERE GROUPED ACCORDING TO THE STUMP CLOSURE TECHNIQUE; A STAPLER GROUP (ENDOPATH-ENDOCUTTER ATG45, ETHICON ENDO-SURGERY, CINCINNATI, OH, USA) (104 PATIENTS; 31.2 %) AND AN ENDOLOOP GROUP (VICRYL-ENDOLOOP 0; ETHICON ENDO-SURGERY, (B)(6) USA) (229 PATIENTS; 68.8 %). THE MESOAPPENDIX WAS DISSECTED, DEPENDING ON THE SURGEONS¿ PREFERENCES, WITH EITHER A HARMONIC SCALPEL (ULTRACISIONTM, ETHICON ENDO-SURGERY, (B)(6) USA), A BIPOLAR TISSUE SEALING SYSTEM (LIGASURETM, VALLEYLAB, BOULDER, CO, USA) OR USING THERMAL FUSION TECHNOLOGY (MISEALTM, MICROLINE). AMONG THE 333 PATIENTS WHO UNDERWENT LA, THERE WAS ONE CASE OF BLEEDING FROM THE MESOAPPENDIX). POSTOPERATIVE COMPLICATIONS WERE SEVEN (2.1 %) WOUND INFECTIONS (FOUR IN THE STAPLER GROUP, THREE IN THE LOOP GROUP), SEVEN (2.1 %) INTRAABDOMINAL ABSCESSES (THREE IN THE STAPLER GROUP, FOUR IN THE LOOP GROUP), FIVE (1.5 %) SMALL BOWEL OBSTRUCTIONS (TWO IN THE STAPLER GROUP, THREE IN THE LOOP GROUP), FIVE (1.5 %) SMALL BOWEL OBSTRUCTIONS (TWO IN THE STAPLER GROUP, THREE IN THE LOOP GROUP), AND ONE (0.3 %) APPENDIX STUMP INSUFFICIENCY IN THE LOOP GROUP. THE AUTHORS PERFORMED A REOPERATION IN ONLY THREE PATIENTS. IN CONCLUSION, THERE IS NO CLINICAL EVIDENCE SUPPORTING THE ROUTINE USE OF ENDOSCOPIC STAPLERS. THE APPENDICEAL STUMP CAN BE SECURED SAFELY WITH THE USE OF ENDOLOOPS IN THE MAJORITY OF PATIENTS. SURGEONS HAVE TO BE MORE SELECTIVE WHEN CHOOSING HOW TO PERFORM CLOSURE, AND AN ENDOSTAPLER SHOULD BE USED ONLY IN CASES WHERE IT IS CLINICALLY INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3006 45MM ARTICNG LNR CUTR/GRN RLD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036001065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention