BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 12586749 · Received October 6, 2021

    Report

    Report Number
    2210968-2021-09299
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 1, 2020
    Report Date
    September 17, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GEA
    PMA / PMN Number
    K925914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE AND ENDOLOOP SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (ILEUS, DYSPEPSIA, SUPERFICIAL/DEEP SURGICAL SITE INFECTION AND POST-OPERATIVE PAIN) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE AND ENDOLOOP SUTURE) USED IN ALL THESE CASES DESCRIBED IN THIS STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (ILEUS, DYSPEPSIA, SUPERFICIAL/DEEP SURGICAL SITE INFECTION AND POST-OPERATIVE PAIN)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: INTERNATIONAL JOURNAL OF COLORECTAL DISEASE (2021) 36:75¿82. HTTPS://DOI.ORG/10.1007/S00384-020-03725-5. EVENTS WERE SUBMITTED VIA 2210968-2021-09298.

    Description of Event or Problem · 0

    TITLE: SURGICAL RECTUS SHEATH BLOCK COMBINED WITH MULTIMODAL PAIN MANAGEMENT REDUCES POSTOPERATIVE PAIN AND ANALGESIC REQUIREMENT AFTER SINGLE-INCISION LAPAROSCOPIC APPENDECTOMY: A RETROSPECTIVE STUDY. THIS RETROSPECTIVE STUDY AIMS TO EVALUATE THE IMPACT OF MULTIMODAL PAIN MANAGEMENT ON PERIOPERATIVE OUTCOMES, INCLUDING POSTOPERATIVE PAIN, BY APPLYING AN RECTUS SHEATH (RS) BLOCK DURING SINGLE-INCISION LAPAROSCOPIC APPENDECTOMY (SILA). FROM JANUARY 2016 TO JANUARY 2020, DATA FROM PATIENTS WHO UNDERWENT LAPAROSCOPIC APPENDECTOMY (DUE TO APPENDICITIS) AT THE CATHOLIC UNIVERSITY OF KOREA SEOUL ST. MARY¿S HOSPITAL WERE RETROSPECTIVELY COLLECTED. 93 PATIENTS WHO UNDERWENT SINGLE-INCISION LAPAROSCOPIC APPENDECTOMY (SILA) WERE SELECTED FOR RETROSPECTIVE ANALYSIS.GROUP 1 CONSISTED OF 40 SINGLE-INCISION LAPAROSCOPIC APPENDECTOMY (SILA) PATIENTS ( 21 MALES AND 19 FEMALES) WITH 4 PATIENTS AGE AGE > 60 YEARS WHO RECEIVED MULTIMODAL PAIN MANAGEMENT THAT INCLUDED INTRAOPERATIVELY APPLYING A SURGICAL RECTUS SHEATH (RS) BLOCK (FROM APRIL 2019 TO JANUARY 2020). GROUP 2 CONSISTED OF 53 SINGLE-INCISION LAPAROSCOPIC APPENDECTOMY (SILA) PATIENTS (26 MALES AND 27 FEMALES) WITH 7 AGE > 60 YEARS WHO RECEIVED CONVENTIONAL PAIN MANAGEMENT WITH INTRAVENOUS OPIOIDS (FROM JANUARY 2016 TO MARCH 2019). WE RETROSPECTIVELY COLLECTED DATA FROM PATIENTS WHO UNDERWENT SINGLE-INCISION LAPAROSCOPIC APPENDECTOMY (SILA) (DUE TO APPENDICITIS) FROM AUGUST 2019 TO JANUARY 2020 AT ST. VINCENT¿S HOSPITAL. GROUP 3 CONSISTED OF 42 SINGLE-INCISION LAPAROSCOPIC APPENDECTOMY (SILA) PATIENTS (19 MALES AND 23 FEMALES) WITH 6 PATIENTS AGE > 60 YEARS WHO RECEIVED MULTIMODAL PAIN MANAGEMENT WITHOUT RECTUS SHEATH (RS) BLOCK. DURING SINGLE-INCISION LAPAROSCOPIC APPENDECTOMY , THE APPENDIX WAS LIGATED AT THE BASE WITH A VICRYL¿ ENDO-LOOP® (ETHICON, INC., SOMERVILLE, NJ, USA) AND SUBSEQUENTLY DIVIDED. THE UMBILICAL FASCIA WAS CLOSED WITH A VICRYL¿ SIZE 1.0 SUTURE. THE SKIN INCISION WAS CLOSED IN A SUBCUTICULAR FASHION USING A VICRYL¿ SIZE 4.0 SUTURE, AND STERI-STRIPS¿ (3 M HEALTHCARE, ST. PAUL, MN, USA) WERE APPLIED ON THE UMBILICUS. REPORTED COMPLICATIONS INCLUDED: ILEUS: GROUP II (N=1). DYSPEPSIA: GROUP I (N=1), GROUP II (N=1). SUPERFICIAL/DEEP SURGICAL SITE INFECTION : GROUP II (N=3), GROUP III (N=2) . POSTOPERATIVE PAIN , WITH MEDIAN AND MAX POSTOPERATIVE VAS SCORES IN GROUP 1 (1.6 ± 1.2 AND 2.2 ± 1.8, RESPECTIVELY) , IN GROUP 2 (3.0 ± 1.2 AND 4.2 ± 1.9, RESPECTIVELY; P < 0.001 ON BOTH ACCOUNTS) AND GROUP 3 (2.9 ± 0.6 AND 3.4 ± 1.2, RESPECTIVELY; P < 0.001 ON BOTH ACCOUNTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482508 ENDOLOOP LIGATURE UNKNOWN PRODUCT LAPROSCOPE, GENERAL & PLASTIC SURGERY GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention