BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 8208528 · Received January 2, 2019

    Report

    Report Number
    3005075853-2019-15433
    Event Type
    Injury
    Date Received
    January 2, 2019
    Report Date
    December 6, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH 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
    1563 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention