BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 12782642 · Received November 9, 2021

    Report

    Report Number
    3005075853-2021-06764
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    July 25, 2021
    Report Date
    November 9, 2021
    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 · 0

    (B)(4). BATCH # UNK. 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/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: USE OF HEM-O-LOK CLIPS FOR LAPAROSCOPIC APPENDECTOMY IN CHILDREN: RETROSPECTIVE ANALYSIS AND COMPARISON TO LIGATURE LOOP AND ENDOSCOPIC SURGICAL STAPLER AUTHOR: ENNIO J. FUENTES1, EDUARDO A. PÉREZ2, RICARDO DÍEZ1, PABLO AGUADO1, CECILIA MORENO1, HENAR SOUTO3, JOSE L. ALONSO3 CITATION: TRANSL GASTROENTEROL HEPATOL 2021;6:44 / HTTP://DX.DOI.ORG/10.21037/TGH-20-213 THIS STUDY AIMS TO COMPARE DIFFERENT DEVICES USED TO CONTROL THE BASE OF THE APPENDIX AND THEIR RELIABILITY. SPECIFICALLY, THE SAFETY AND EFFICACY OF THE HEM-O-LOK CLIP (HOL). FROM JUNE 2016 TO DECEMBER 2019, 253 CONSECUTIVE CHILDREN AGED TO 1 TO 18 YEARS UNDERWENT A LAPAROSCOPIC APPENDECTOMY. SIXTY THREE PERCENT WERE MALE (N=159). ALL THE PATIENTS WHO UNDERWENT THE AFOREMENTIONED SURGERY PRESENTED WITH A CLINICAL PICTURE OF ACUTE APPENDICITIS. THE PATIENTS WERE DIVIDED INTO THREE GROUPS, ACCORDING TO THE DEVICE USED TO LIGATE THE BASE OF THE APPENDIX: LIGATURE LOOP (LL) (PDS II VIOLET MONOFILAMENT POLYDIOXANONE SUTURE 0 (53 CM) ETHICON SOMERVILLE, NEW JERSEY, USA, SURGICAL STAPLER (SS) (ENDOPATH ETS-FLEX-ENDOSCOPIC ARTICULATING LINEAR CUTTER 33 MM STANDARD REF ATB 35. ETHICON, SOMERVILLE, NEW JERSEY, USA) AND HEM-O-LOK CLIPS (HOL) (WECK CLOSURE SYSTEM. TRIANGLE PARK, NC, USA). THE FIRST GROUP RECEIVED DOUBLE LIGATURE LOOP (LL) WITH 9 PATIENTS (7 MALES) WITH MEAN AGE OF 10.3±4.1 YEARS , WHILE THE SURGICAL STAPLER (SS) WAS USED IN THE SECOND WITH 46 PATIENTS (30 MALES) WITH MEAN AGE OF 9.4±2.7 YEARS , AND THE BASE WAS SECURED BY A TWO LARGE NON-ABSORBABLE CLIPS HEM-O-LOK CLIPS (HOL) IN THE THIRD GROUP WITH 199 PATIENTS (122 MALES) WITH MEAN AGE OF 10.4±3.3 YEARS. REPORTED COMPLICATIONS INCLUDED: INTRAABDOMINAL ABSCESSES PRESENTED IN (N=1) OF PATIENTS IN THE LIGATURE LOOP (LL) GROUP, (N=4) IN THE SURGICAL STAPLER (SS) GROUP ,ALL CASES WERE INITIALLY TREATED WITH BROAD-SPECTRUM ANTIBIOTICS, ACCORDING TO THE STANDARD PROTOCOL ESTABLISHED FOR THIS PURPOSE (AMOXICILLIN/CLAVULANATE 100/MG/KG/DAY + GENTAMICIN 5 MG/KG/DAY). IF NOT RESPONDING APPROPRIATELY, THEY REQUIRED CONVERSION TO A DIFFERENT ANTIBIOTIC REGIMEN (MEROPENEM 60 MG/KG/DAY).RIGHT SHOULDER PAIN WAS REPORTED BY (N=2) OF PATIENTS IN THE LIGATURE LOOP (LL) GROUP, (N=8) IN THE SURGICAL STAPLER (SS) GROUP. IT WAS CONCLUDED, THAT OUR DATA SHOWS THAT THE USE OF HEM-O-LOCK CLIPS IS SAFE, EFFECTIVE AND ITS USE REDUCES SURGICAL COSTS WHEN COMPARED WITH OTHER MORE COMMON TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680865 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention