BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 7422373 · Received April 11, 2018

    Report

    Report Number
    3005075853-2018-09071
    Event Type
    Injury
    Date Received
    April 11, 2018
    Report Date
    March 23, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT THE POST-COMPLICATIONS ARE RELATED TO AN ALLEGED DEFICIENCY OF AN ETHICON DEVICE?

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 04/27/2018. REPORT SUBMISSION DUE DATE = (B)(6) 2018.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: ENDOLOOP VERSUS ENDOSTAPLER CLOSURE OF THE APPENDICEAL STUMP IN PEDIATRIC LAPAROSCOPIC APPENDECTOMY, CITATION: CAN J SURG, VOL. 55, NO. 1, FEBRUARY 2012; DOI: 10.1503/CJS.023810. THE AIM OF THIS STUDY WAS TO COMPARE INFECTIOUS OUTCOMES BETWEEN 2 LAPAROSCOPIC TECHNIQUES OF APPENDICEAL STUMP CLOSURE: ENDOLOOP (EL) AND ENDOSTAPLER (ES). A TOTAL OF 242 PATIENTS UNDERWENT LA DURING THE STUDY PERIOD AND HAD COMPLETE DATA SETS ABSTRACTED RETROSPECTIVELY FROM THEIR MEDICAL RECORDS. THE PATIENT WERE DIVIDED INTO 2 GROUPS: NON-PERFORATED APPENDICITIS (NPA) N=185, PERFORATED APPENDICITIS (PA) N=57. ONE SURGEON USED THE ES (ETHICON ENDOSURGERY) IN ALL CASES (PA AND NONPERFORATED APPENDICITIS [NPA]) WHEREAS 2 SURGEONS ROUTINELY USED EL UNLESS THE CONDITION OF THE APPENDICEAL BASE FAVOURED USE OF AN ES TO ENSURE SEALING OF HEALTHY TISSUE. ENDOLOOP STUMP CLOSURE CONSISTED OF 2 PROXIMAL AND 1 DISTAL 2¿0 POLYDIOXANONE (PDS; ETHICON) ELS, WITH DIVISION OF THE APPENDICEAL BASE BETWEEN THE MIDDLE AND DISTAL EL. SURGICAL SITE INFECTIONS (NPA (N=2); PA (N=2)) AND INTRA-ABDOMINAL ABSCESS FORMATION (NPA (N=5); PA (N=6) WITH THE USE OF EL WERE REPORTED. INTRA-ABDOMINAL ABSCESS FORMATION (N=5) WITH THE USE OF ENDOSTAPLER WAS ALSO REPORTED. IN CONCLUSION, THIS STUDY SUGGESTS THAT PREFERENTIAL USE OF EL FOR APPENDICEAL STUMP CLOSURE IN LA IS ASSOCIATED WITH AT LEAST EQUIVALENT INFECTIOUS OUTCOMES, AS WELL AS COST SAVINGS, IN COMPARISON TO ROUTINE USE OF ES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263427 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1