BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 8208041 · Received January 2, 2019

    Report

    Report Number
    3005075853-2019-15430
    Event Type
    Injury
    Date Received
    January 2, 2019
    Report Date
    December 5, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 IN JOURNAL ARTICLE TITLE: "LOOPED SUTURE VERSUS STAPLER DEVICE IN PEDIATRIC LAPAROSCOPIC APPENDECTOMY: A COMPARATIVE OUTCOMES AND INTRAOPERATIVE COST ANALYSIS." AUTHOR(S): PUNAM P. PARIKH, JUN TASHIRO, AMY E.WAGENAAR, MIOSOTYS CURBELO, EDUARDO A. PEREZ, HOLLY L. NEVILLE, ANTHONY R. HOGAN, JUAN E. SOLA. CITATION: JOURNAL OF PEDIATRIC SURGERY 53 (2018) 616¿619; DOI: HTTP://DX.DOI.ORG/10.1016/J.JPEDSURG.2017.05.016. THE PURPOSE OF THIS STUDY WAS TO COMPARE CLINICAL OUTCOMES IN ADDITION TO INTRAOPERATIVE COST AFTER APPLICATION OF LOOPED SUTURE VERSUS STAPLER FOR STUMP CLOSURE IN PEDIATRIC PATIENTS UNDERGOING LAPAROSCOPIC APPENDECTOMY (LA) FOR APPENDICITIS. FROM FISCAL YEARS 2013 TO 2014, 238 PATIENTS UNDERWENT LA AND WERE STRATIFIED BY TYPE OF APPENDICEAL LIGATION: LOOP SUTURE (N=110) AND STAPLER LIGATION (N=128). IN THE PROCEDURE, THE APPENDIX WAS DIVIDED BETWEEN DISTAL GRASPER AND TWO ENDOLOOP PDS II WAS PLACED AT THE BASE OF THE APPENDIX OR WITH AN ENDOPATH ETS STAPLER/CUTTER, ETHICON (WHITE LOAD FOR THE MESOAPPENDIX AND BLUE LOAD FOR THE APPENDIX). THE MESOAPPENDIX IN THIS GROUP OF PATIENTS WAS DIVIDED WITH THE USE OF CAUTERY. IN HOSPITAL COMPLICATIONS INCLUDED RIGHT LOWER QUADRANT PELVIC ABSCESS (N=2) IN ENDOLOOP GROUP AND INTRA-ABDOMINAL ABSCESS (N=1) IN STAPLER GROUP. IN A 30-DAY RETURN TO ER ON ENDOLOOP GROUP, OUTCOMES INCLUDED NON-SPECIFIC ABDOMINAL PAIN (N=2), AND INTRA-ABDOMINAL ABSCESS (N=2) TO WHICH PATIENTS WERE READMITTED FOR DRAINAGE OF INTRA-ABDOMINAL ABSCESS AND PARENTERAL ANTIBIOTIC THERAPY. WHILE IN A 30-DAY RETURN TO ER ON STAPLER GROUP, OUTCOMES INCLUDED NON-SPECIFIC ABDOMINAL PAIN (N=2) OF WHICH ONE WAS TREATED CONSERVATIVELY, CONSTIPATION/ILEUS (N=3) WHICH WERE MANAGED CONSERVATIVELY, ABDOMINAL WALL ABSCESS (N=2) TREATED WITH DEBRIDEMENT, AND INTRA-ABDOMINAL ABSCESS (N=1) TREATED WITH DRAINAGE. THERE IS A HIGHER INCIDENCE OF INTRA-ABDOMINAL INFECTION AND ABSCESS FORMATION WHEN LOOPED SUTURE IS USED IN LIEU OF STAPLER DEVICE, EVEN IN PATIENTS WITH ACUTE NON PERFORATED APPENDICITIS. THIS ASSOCIATION MAY BE ATTRIBUTED TO INSUFFICIENT CLOSURE OF THE APPENDICEAL STUMP WITH LOOPED SUTURE, EXPOSURE OF CONTAMINATED MUCOSA AT THE CUT EDGES TO THE ABDOMINAL CAVITY, OR MUCOSAL NECROSIS IF LOOPS LOOSEN. A COMPARATIVE ANALYSIS OF LOOPED SUTURE VERSUS STAPLER DEVICE DURING LA FOR PEDIATRIC APPENDICITIS REVEALED THAT POSTOPERATIVE COMPLICATIONS, LENGTH OF STAY, ER VISITS AND READMISSIONS WERE NOT SIGNIFICANTLY DIFFERENT. LOOPED SUTURE LA WAS SIGNIFICANTLY MORE COST EFFICIENT THAN STAPLER LA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2993 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention