BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8809860 · Received July 20, 2019

    Report

    Report Number
    2210968-2019-84498
    Event Type
    Injury
    Date Received
    July 20, 2019
    Report Date
    June 25, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: DIG SURG 2007; 24:382¿387; DOI: 10.1159/000107780; PUBLISHED ONLINE: AUGUST 31, 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: PROSPECTIVE, RANDOMIZED TRIAL COMPARING A 3- VERSUS 6-STITCH PURSE-STRING SUTURE IN STAPLED HEMORRHOIDOPEXY" AUTHORS: YASUHIRO INOUE, MINAKO KOBAYASHI, SHIGEYUKI YOSHIYAMA, JUNICHIRO HIRO, MASAKI OHI, CHIKAO MIKI AND MASATO KUSUNOKI CITATION: DIG SURG 2007; 24:382¿387; DOI: 10.1159/000107780; PUBLISHED ONLINE: AUGUST 31, 2007. THIS PROSPECTIVE, RANDOMIZED STUDY AIMED TO EVALUATE THE SAFETY AND CLINICAL OUTCOME OF A 6-STITCH PURSE-STRING SUTURE COMPARED WITH A MORE SIMPLE 3-STITCH PURSE-STRING SUTURE INTENDED TO ACHIEVE CERTAIN INTERRUPTION OF THE HEMORRHOIDAL ARTERY. BETWEEN SEPTEMBER 2002 TO NOVEMBER 2006, NINETY PATIENTS WERE RANDOMLY ASSIGNED TO UNDERGO STAPLED HEMORRHOIDOPEXY WITH EITHER A 6-STITCH (LONGO (L) PROCEDURE, N=45) (MEAN AGE 60.8 ±16.0 YEARS, MALE N=26, FEMALE N=19) OR A 3-STITCH (SINGAPORE (S) PROCEDURE, N=45) (MEAN AGE 54.7 ±16.3 YEARS, MALE N=29, FEMALE N=16) PURSE-STRING SUTURE. STAPLED HEMORRHOIDOPEXY WAS PERFORMED USING THE ETHICON PPH33 CIRCULAR STAPLER (ETHICON ENDO-SURGERY). AN INSTRUMENT KIT PPH-01 (CLOSED STAPLE HEIGHT RANGE 1¿2.5 MM) WAS USED FROM SEPTEMBER 2001 TO APRIL 2004, AND THE NEW PPH-03 (CLOSED STAPLE HEIGHT RANGE 0.75¿1.5 MM) WAS USED FROM MAY 2004. THE PURSE STRING ANOSCOPE (ETHICON ENDOSURGERY) WAS THEN INTRODUCED THROUGH THE CAD33, AND A CIRCUMFERENTIAL PURSE-STRING SUTURE OF 2-0 POLYPROPYLENE WAS PLACED 4 CM PROXIMAL TO THE DENTATE LINE. A 30-MM CURVED, ROUND BODIED NEEDLE WAS USED FOR THE S PROCEDURE. A 26MM CURVED, ROUND-BODIED NEEDLE WAS USED FOR THE L PROCEDURE. THE CIRCULAR STAPLER WAS OPENED TO ITS MAXIMUM POSITION AND POSITIONED PROXIMAL TO THE PURSE-STRING. THE PURSE-STRING WAS THEN TIGHTENED. THE STAPLER WAS THEN FIRED AND HELD IN POSITION FOR 30 SECONDS TO ENSURE HEMOSTASIS. THE STAPLED LINE WAS INSPECTED FOR ANY BLEEDING AND, IF PRESENT, HEMOSTATIC SUTURES WERE PLACED WITH 3-0 VICRYL. IN ALL CASES, SPONGOSTAN WAS PLACED IN THE ANAL CANAL TO PREVENT POSTOPERATIVE BLEEDING. COMPLICATIONS INCLUDED ANAL FISSURE (N=4), HEMATOMA (N=1) AND PAIN (N=3) IN THE 3-STITCH GROUP AND POSTOPERATIVE BLEEDING (N=1) IN WHICH THE PATIENT REQUIRED EMERGENCY RETURN TO THE OPERATING THEATER TO CONTROL THE BLEEDING UNDER ANESTHESIA; ANAL FISSURE (N=3), HEMATOMA (N=1) AND PAIN (N=2) IN THE 6-STITCH GROUP. IN CONCLUSION, ONCE THE LEARNING CURVE HAS BEEN COMPLETED, A 3-STITCH PURSE-STRING SUTURE IN STAPLED HEMORRHOIDOPEXY COULD BE AN ALTERNATIVE TO THE 6-STITCH SUTURE, WITH EFFECTIVE HEMOSTASIS AND A SHORTER OPERATIVE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603608 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention