BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8717676 · Received June 20, 2019

    Report

    Report Number
    2210968-2019-83053
    Event Type
    Injury
    Date Received
    June 20, 2019
    Report Date
    May 27, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. CITATION: TECH COLOPROCTOL (2011) 15:267¿271 / DOI: 10.1007/S10151-011-0699-Z. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: OUTCOME OF STAPLED HEMORRHOIDOPEXY VERSUS DOPPLER-GUIDED HEMORRHOIDAL ARTERY LIGATION FOR GRADE III HEMORRHOIDS" AUTHOR(S): S. AVITAL, R. ITAH, Y. SKORNICK, R. GREENBERG. CITATION: TECH COLOPROCTOL (2011) 15:267¿271 / DOI: 10.1007/S10151-011-0699-Z. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE RESULTS OF THESE TWO METHODS IN TERMS OF POSTOPERATIVE PAIN, POSTOPERATIVE COMPLICATIONS, EFFECTIVENESS IN SYMPTOM CONTROL, RECURRENCE RATE, AND PATIENT SATISFACTION. FROM JAN 2005 TO DEC 2006, A TOTAL OF 114 PATIENTS, OVER 18 YEARS OF AGE, WITH SYMPTOMATIC GOLIGHER GRADE III INTERNAL HEMORRHOIDS IN AT LEAST THREE QUADRANTS UNDERWENT STAPLED HEMORRHOIDOPEXY (SH) [N=63 (N=30 FEMALE, N-33 MALE, MEAN AGE 52 ± 3.2 YEARS)] OR DOPPLER-GUIDED HEMORRHOIDAL ARTERY LIGATION (DGHAL) [N=51 (N=29 FEMALE, N=22 MALE, MEAN AGE 50 ± 73. YEARS)]. IN SH GROUP, THE PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER PPH 01 (ETHICON ENDO SURGERY) KIT WAS USED FOR ALL PATIENTS. THE CIRCULAR ANOSCOPE WAS INSERTED TO REDUCE THE PROLAPSING ANODERM AND TO ALLOW PLACEMENT OF A CIRCUMFERENTIAL PURSE STRING SUTURE 3¿4 CM ABOVE THE DENTATE LINE INTO THE MUCOSA AND SUBMUCOSA. THE STAPLER WAS THEN CLOSED AND ADVANCED INTO THE ANAL CANAL, WHILE TRACTION WAS MAINTAINED ON THE PURSE STRING SUTURE. AROUND TWENTY SECONDS LATER, THE STAPLER WAS CLOSED AND FIRED. IN DGHAL GROUP, A 6-10 FIGURES OF EIGHT STITCHES WERE PERFORMED USING VICRYL 2/0 WITH A 5/8 CURVED NEEDLE THROUGH THE ANOSCOPE WINDOW. LIGATION OF THE VESSEL WAS CONFIRMED BY THE ABSENCE OF THE DOPPLER ARTERIAL SIGNAL DISTAL TO THE SUTURE LINE. POSTOPERATIVE COMPLICATIONS INCLUDED PAIN [N=80, (N=63 SH GROUP AND N=17 DGHAL GROUP)] WHICH ALL REQUIRED VARYING AMOUNTS OF ANALGESIA; AND HEMORRHOIDAL BLEEDING AND PROLAPSE [N=11, (N=2 IN SH GROUP AND N=9 IN DGHAL GROUPS)] WHICH ONE OF THE PATIENTS IN SH GROUP UNDERWENT CONVENTIONAL HEMORRHOIDECTOMY FOR CONTROL OF STAPLE LINE BLEEDING BY SUTURING, WHILE THE OTHER IN SH GROUP REFUSED ADDITIONAL TREATMENT. FIVE OF THESE PATIENTS IN DGHAL GROUP WERE REOPERATED, ONE UNDERWENT RUBBER BAND LIGATION, WHILE THE OTHER THREE PATIENTS REFUSED ADDITIONAL TREATMENTS. BOTH SH AND DGHAL ARE SAFE AND EFFECTIVE METHODS FOR TREATING GRADE III HEMORRHOIDS. EACH OF THEM MAY BE CONSIDERED AS A SUITABLE ALTERNATIVE TO CONVENTIONAL HEMORRHOIDECTOMY WITH NO RISK OF POSTOPERATIVE STOOL INCONTINENCE, MINIMAL POSTOPERATIVE PAIN, AND A HIGH PATIENT SATISFACTION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511893 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention