BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 8200164 · Received December 27, 2018

    Report

    Report Number
    2210968-2018-78049
    Event Type
    Injury
    Date Received
    December 27, 2018
    Report Date
    December 5, 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 · 0

    (B)(4). DATE SENT TO THE FDA: 01/08/2019. CORRECTED INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THIS EVENT DOES NOT MEET REPORTING CRITERIA. THIS EVENT THEREFORE IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. NO. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ENDOLOOP VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? NO. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ENDOLOOP VICRYL SUTURE) USED IN THIS PROCEDURE? NO.

    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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ENDOLOOP VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (ENDOLOOP VICRYL SUTURE) USED IN THIS PROCEDURE? CITATION: SURG TODAY (2014) 44: 1716¿1722; DOI 10.1007/S00595-013-0818-8; PUBLISHED ONLINE: 12 DECEMBER 2013; K925914. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "ANALYSIS OF ENDOLOOPS AND ENDOSTAPLES FOR CLOSING THE APPENDICEAL STUMP DURING LAPAROSCOPIC APPENDECTOMY." AUTHORS: MISLAV RAKIC, MIRO JUKIC, ZENON POGORELIC, IVANA MRKLIC, ROBERT KLICEK, NIKICA DRUZIJANIC, ZDRAVKO PERKO AND LEONARDO PATRLJ. CITATION: SURG TODAY (2014) 44: 1716¿1722; DOI 10.1007/S00595-013-0818-8; PUBLISHED ONLINE: 12 DECEMBER 2013. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICIENCY OF EACH TECHNIQUE BY FOCUSING ON THE INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS VERSUS COST. BETWEEN JUNE 2011 AND JUNE 2013, A TOTAL OF 333 PATIENTS (188 MALES AND 155 FEMALES WITH AGE RANGE FROM 5 TO 80 YEARS OLD) WHO UNDERWENT LAPAROSCOPIC APPENDECTOMY (LA) WERE INCLUDED. THE DATA WERE GROUPED ACCORDING TO THE STUMP CLOSURE TECHNIQUE; A STAPLER GROUP (ENDOPATH-ENDOCUTTER ATG45, ETHICON ENDO-SURGERY, CINCINNATI, OH, USA) (104 PATIENTS; 31.2 %) AND AN ENDOLOOP GROUP (VICRYL-ENDOLOOP 0; ETHICON ENDO-SURGERY, CINCINNATI, OH, USA) (229 PATIENTS; 68.8 %). THE MESOAPPENDIX WAS DISSECTED, DEPENDING ON THE SURGEONS¿ PREFERENCES, WITH EITHER A HARMONIC SCALPEL (ULTRACISION TM, ETHICON ENDO-SURGERY, CINCINNATI, OH, USA). AMONG THE 333 PATIENTS WHO UNDERWENT LA, THERE WAS ONE CASE OF BLEEDING FROM THE MESOAPPENDIX). POSTOPERATIVE COMPLICATIONS WERE SEVEN (2.1 %) WOUND INFECTIONS (FOUR IN THE STAPLER GROUP, THREE IN THE LOOP GROUP), SEVEN (2.1 %) INTRAABDOMINAL ABSCESSES (THREE IN THE STAPLER GROUP, FOUR IN THE LOOP GROUP), FIVE (1.5 %) SMALL BOWEL OBSTRUCTIONS (TWO IN THE STAPLER GROUP, THREE IN THE LOOP GROUP), FIVE (1.5 %) SMALL BOWEL OBSTRUCTIONS (TWO IN THE STAPLER GROUP, THREE IN THE LOOP GROUP), AND ONE (0.3 %) APPENDIX STUMP INSUFFICIENCY IN THE LOOP GROUP. THE AUTHORS PERFORMED A REOPERATION IN ONLY THREE PATIENTS. IN CONCLUSION, THERE IS NO CLINICAL EVIDENCE SUPPORTING THE ROUTINE USE OF ENDOSCOPIC STAPLERS. THE APPENDICEAL STUMP CAN BE SECURED SAFELY WITH THE USE OF ENDOLOOPS IN THE MAJORITY OF PATIENTS. SURGEONS HAVE TO BE MORE SELECTIVE WHEN CHOOSING HOW TO PERFORM CLOSURE, AND AN ENDOSTAPLER SHOULD BE USED ONLY IN CASES WHERE IT IS CLINICALLY INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039669 ENDOLOOP LIGATURE UNKNOWN PRODUCT CANNULA, SURGICAL, GENERAL GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention