BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 12739855 · Received November 2, 2021

    Report

    Report Number
    2210968-2021-10754
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    June 20, 2013
    Report Date
    November 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GEA
    PMA / PMN Number
    K925914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURGERY 2014 ¿ 85:46-50 DOI10.1007/S00104-013-2549-1.

    Description of Event or Problem · 0

    TITLE: STUMP CLOSURE IN LAPAROSCOPIC APPENDECTOMY EFFECTS OF THE ENDOSCOPIC SLING OR THE LINEAR STAPLER ON THE PATIENT¿S OUTCOME. THE AIM OF THE PRESENT STUDY WAS THEREFORE TO COMPARE THE ENDOLOOP AND STAPLER TECHNIQUE WITH REGARD TO THE OUTCOME PARAMETERS OF WOUND INFECTION (WI) AND INTRA-ABDOMINAL ABSCESS (IAA) AS PART OF A RETROSPECTIVE TRIAL. FROM 01.01.2007 TO 31.05, A TOTAL OF 430 APPENDECTOMIES WERE PERFORMED .OF THESE, 114 OPERATIONS WERE STARTED LAPAROSCOPICALLY. IN 9 CASES, A CONVERSION WAS NECESSARY, SO THAT A TOTAL OF 105 OPERATIONS WERE LAPAROSCOPICALLY COMPLETED AND INCLUDED IN THE STUDY. IN THIS STUDY (N=50) , 9 MALES AND 41 FEMALES AGE 27 (10-65 YEARS ) ,WERE ALLOTTED TO THE LINEAR STAPLER GROUP (LSG) AND (N=55) , 15 MALES AND 40 FEMALES AGE 23 (5-62 YEARS ) TO ENDOLOOP GROUP (ELG). DURING LAPAROSCOPIC APPENDECTOMY, THE CLOSURE OF THE APPENDIX STUMP OCCURRED IN THE LINEAR STAPLER GROUP (LSG) WITH A LINEAR STAPLES (MULTIFIRE ENDO GIA 30, COVIDIEN, MANSFIELD, USA) AND IN THE ENDOLOOP GROUP (ELG) WITH AN ENDOLOOP (PDSII 0 18'' 12, ETHICON ENDO-SURGERY, CINCINNATI, USA). REPORTED COMPLICATION INCLUDED: (N=4) WOUND INFECTIONS , WHICH WERE TREATED BY OPENING THE WOUND. (N=2) INTRA-ABDOMINAL ABSCESS (IAA) ,WERE TREATED BY INTERVENTIONAL DRAINAGE OR SURGERY. IT WAS CONCLUDED, THAT THE CLOSURE OF THE APPENDIX STUMP USING AN ENDOLOOP IN THE LAPAROSCOPIC APPENDECTOMY IS A COST-EFFECTIVE ALTERNATIVE TO THE USE OF LINEAR STAPLER, WHILE MAINTAINING THE SAME LEVEL OF PATIENT SECURITY. IT HAS BEEN SHOWN THAT THE USE OF ENDOLOOPS, ESPECIALLY IN LOW-GRADE INFLAMMATIONS (CATARRHAL AND PHLEGMONOUS APPENDICITIS) HAS LED TO GOOD RESULTS AND A COMPLICATION-FREE COURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636583 ENDOLOOP LIGATURE UNKNOWN PRODUCT LAPROSCOPE, GENERAL & PLASTIC SURGERY GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention