BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUT CHROMIC SUTURE UNKNOWN PRODUCT

    MDR report key: 8374149 · Received February 27, 2019

    Report

    Report Number
    2210968-2019-79102
    Event Type
    Injury
    Date Received
    February 27, 2019
    Report Date
    February 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    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 (GUT OR 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 (GUT OR VICRYL SUTURE) USED IN THIS PROCEDURE? CITATION: GASTROENTEROLOGY RESEARCH AND PRACTICE VOLUME 2016, ARTICLE ID 8143703, 8 PAGES; DOI: HTTP://DX.DOI.ORG/10.1155/2016/8143703. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "A RANDOMIZED CONTROLLED TRIAL COMPARING SUTURE-FIXATION MUCOPEXY AND DOPPLER-GUIDED HEMORRHOIDAL ARTERY LIGATION IN PATIENTS WITH GRADE III HEMORRHOIDS." AUTHOR(S): MIN ZHAI, YONG-AN ZHANG, ZHEN-YI WANG, JIAN-HUA SUN, JIEWEN, QI ZHANG, JIN-DE LI, YI-ZHENGWU, FENG ZHOU, AND HUI-LEI XU. CITATION: GASTROENTEROLOGY RESEARCH AND PRACTICE VOLUME 2016, ARTICLE ID 8143703, 8 PAGES; DOI: HTTP://DX.DOI.ORG/10.1155/2016/8143703. THIS RANDOMIZED CONTROLLED TRIAL AIMED TO EVALUATE THE EFFECTIVENESS OF A SUTURE-FIXATION MUCOPEXY PROCEDURE BY COMPARING WITH DOPPLER-GUIDED HEMORRHOIDAL ARTERY LIGATION (DGHAL) IN THE MANAGEMENT OF PATIENTS WITH GRADE III HEMORRHOIDS. BETWEEN MAR2010 AND MAY2011, 100 PATIENTS WITH GRADE III HEMORRHOIDS UNDERWENT REPAIR USING SUTURE-FIXATION MUCOPEXY (N=50; N=23 MALE AND N=27 FEMALE; AGE OF 43.60±14.97 YEARS) AND DGHAL (N=50; N=16 MALE AND N=34 FEMALE; AGE OF 50.56±14.44 YEARS). IN SUTURE-FIXATION GROUP, TWO CONTINUOUS SUTURES WERE PERFORMED USING A UR-6, 26 MM, 5/8C VICRYL NEEDLE, AND AN ABSORBABLE 0 CHROMIC CATGUT (ETHICON, US) AT 2MM ABOVE THE DENTATE LINE AND THE STITCHES WERE PASSED THROUGH THE MUCOUS MEMBRANE AND THE MUSCULAR LAYER OF THE RECTAL WALL BENEATH THE PROLAPSING HEMORRHOIDS. IN DGHAL GROUP, A FIGURE-OF-EIGHT SUTURE WAS CONDUCTED USING A UR-6, 26 MM, 5/8C VICRYL NEEDLE, AND AN ABSORBABLE 2-0 CHROMIC CATGUT (ETHICON, US) WHERE THE ARTERY HAD BEEN IDENTIFIED. IN SUTURE FIXATION GROUP COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING (N=2) MANAGED BY SIMPLE LIGATION UNDER LOCAL ANESTHESIA (N=1) AND WITH INTRAVENOUS USE OF HEMOCOAGULASE (N=1); PERSISTENT PROLAPSING HEMORRHOIDS (N=1) MANAGED BY SCLEROTHERAPY; ANAL DISCOMFORT (N=15); MEAN VAS POSTOPERATIVE PAIN OF 3.4±2.8 AT FIRST DAY (N=50); MEAN VAS POSTOPERATIVE PAIN OF 1.7±2.0 AT SECOND DAY (N=50); AND MEAN VAS POSTOPERATIVE PAIN OF 1.0±1.2 AT THIRD DAY (N=50). AT 3 MONTHS POST-PROCEDURE, WEXNER INCONTINENCE GRADING SCALE INCLUDED SCORE OF 1-5 (N=6); SCORE OF 6-10 (N=2); AND SCORE OF 11-15 (N=1). AT 12 MONTHS, OUTCOME INCLUDED OCCASIONAL BLEEDING (N=2). AT 24 MONTHS, OUTCOMES INCLUDED RECURRENT PROLAPSING HEMORRHOIDS (N=1) AND BLEEDING (N=2). IN DGHAL GROUP COMPLICATIONS INCLUDED POSTOPERATIVE OOZING OF BLOOD (N=1) MANAGED BY SIMPLE MECHANICAL COMPRESSION; PERSISTENT PROLAPSING HEMORRHOIDS (N=4) MANAGED BY SCLEROTHERAPY; ANAL DISCOMFORT (N=7); MEAN VAS POSTOPERATIVE PAIN OF 3.0±3.0 AT FIRST DAY (N=50); MEAN VAS POSTOPERATIVE PAIN OF 1.5±1.9 AT SECOND DAY (N=50); MEAN VAS POSTOPERATIVE PAIN OF 0.8±1.4 AT THIRD DAY (N=50). AT 3 MONTHS POST-PROCEDURE, WEXNER INCONTINENCE GRADING SCALE INCLUDED SCORE OF 1-5 (N=4) AND SCORE OF 6-10 (N=3). AT 12 MONTHS, OUTCOMES INCLUDED RECURRENT PROLAPSING HEMORRHOIDS (N=4); AND OCCASIONAL BLEEDING (N=1). AT 24 MONTHS, OUTCOMES INCLUDED RECURRENT PROLAPSING HEMORRHOIDS (N=8) AND BLEEDING (N=2). THE STITCHES MAY ALSO DECREASE THE BLOOD FLOW TO HEMORRHOID CUSHIONS, CONTRIBUTING TO THE SHRINKAGE OF HEMORRHOIDS. SUTURES ARE PERFORMED WELL ABOVE THE DENTATE LINE TO MINIMIZE POSTOPERATIVE PAIN. THESE RESULTS SUGGEST THAT THIS SUTURE FIXATION TECHNIQUE HAS THE POTENTIAL AS AN EFFECTIVE AND AFFORDABLE TREATMENT OPTION FOR PATIENTS WITH SYMPTOMATIC HEMORRHOIDS. THE SUTURE FIXATION MUCOPEXY TECHNIQUE IN OUR STUDY HAD COMPARABLE SHORT-TERM OUTCOMES AND FAVORABLE LONG-TERM OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166811 GUT CHROMIC SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, NATURAL GAL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention