BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 8200596 · Received December 27, 2018

    Report

    Report Number
    2210968-2018-78056
    Event Type
    Injury
    Date Received
    December 27, 2018
    Report Date
    December 6, 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. 2011; 25: 124¿129. DOI: 10.1007/S00464-010-1144-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CURRENT ANALYSIS OF ENDOLOOPS IN APPENDICEAL STUMP CLOSURE". AUTHORS: MAIK SAHM, RAINER KUBE, SYBILLE SCHMIDT, CHRISTINA RITTER, MATTHIAS PROSS, HANS LIPPERT. CITATION: SURG ENDOSC. 2011; 25: 124¿129. DOI: 10.1007/S00464-010-1144-5. AN INADEQUATE CLOSURE OF THE APPENDIX STUMP LEADS TO INTRA-ABDOMINAL SURGICAL SITE INFECTION. THE EFFECTIVENESS OF VARIOUS APPENDICEAL STUMP CLOSURE METHODS, FOR INSTANCE, STAPLERS OR ENDOLOOPS, WAS EVALUATED. THE AIM OF THIS STUDY WAS TO EVALUATE THE COMPLICATION AFTER USING ENDOLOOPS IN A HIGH-VOLUME CENTER. LAPAROSCOPIC APPENDECTOMY WAS PERFORMED IN 1,790 PATIENTS AND OPEN APPENDECTOMY IN 425 PATIENTS. IN LAPAROSCOPIC APPENDECTOMY, STUMP CLOSURE USING ENDOLOOPS (ETHICON) WAS PERFORMED IN 1670 PATIENTS (690 MALE AND 980 FEMALE PATIENTS; AGE RANGE: 8 TO 95 YEARS OLD; BMI 12 TO 50) AND STUMP CLOSURE USING STAPLER WAS USED IN 46 PATIENTS (31 MALE AND 15 FEMALE PATIENTS; AGE RANGE: 11 TO 79 YEARS OLD; BMI 18 TO 36). IN THE LAPAROSCOPIC APPROACH, THE MESOAPPENDIX WAS DISSECTED USING BIPOLAR COAGULATION AND LAPAROSCOPIC SCISSORS. THE AUTHORS PLACED 1 ENDOLOOP LIGATURE PDS II (ETHICON) TO THE APPENDIX BASE. AN ADDITIONAL LOOP WAS PLACED 10 MM DISTALLY. THE BASE WAS CUT WITH LAPAROSCOPIC SCISSORS BETWEEN THE LOOPS. WE DISINFECTED THE APPENDICEAL STUMP WITH POLYVIDONE-IODINE. WHEN THE AUTHORS USED A STAPLER FOR APPENDICEAL STUMP CLOSURE, THE AUTHORS TRANSECTED THE APPENDIX BASE WITH THE ENDOSCOPIC LINEAR CUTTER, WITH ENDOSCOPIC LINEAR CUTTER (ETHICON). IN THE ENDOLOOP GROUP, REPORTED COMPLICATIONS INCLUDED SEROMA (N-13), ABSCESS (N-21), INTRAABDOMINAL ABSCESS (N-27) WHICH REQUIRED RELAPAROSCOPY, RELAPAROTOMY, OR CT DRAINAGE, AND ANTIBIOTIC THERAPY, INSUFFICIENT STUMP CLOSURE (N-2), POSTOPERATIVE BLEEDING (N-3), POSTOPERATIVE PERITONITIS (N-3), MECHANICAL SMALL BOWEL OBSTRUCTION (N-13), AND PARALYTIC SMALL BOWEL OBSTRUCTION (N-23). IN THE STAPLER GROUP, REPORTED COMPLICATIONS INCLUDED INTRAABDOMINAL ABSCESS (N-1) WHICH REQUIRED RELAPAROSCOPY, AND PARALYTIC SMALL BOWEL OBSTRUCTION (N-3). THE STUDY SHOWED THAT THE TREATMENT OF THE APPENDICEAL BASE CAN BE DONE SAFELY WITH THE USE OF ENDOLOOPS (ETHICON) IN THE MAJORITY OF PATIENTS AND A SELECTIVE USE OF A STAPLER IN A SMALL MINORITY OF PATIENTS. APPENDICEAL STUMP CLOSURE USING AN ENDOLOOP IS AN EASY, SAFE, AND COST EFFECTIVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040264 ENDOLOOP LIGATURE UNKNOWN PRODUCT CANNULA, SURGICAL, GENERAL GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention