BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8771849 · Received July 9, 2019

    Report

    Report Number
    2210968-2019-83796
    Event Type
    Injury
    Date Received
    July 9, 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
    EG
    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: INTERNATIONAL SCHOLARLY RESEARCH NETWORK ISRN SURGERY VOLUME 2012, ARTICLE ID 652345, 6 PAGES; DOI:10.5402/2012/652345. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: STAPLED TRANSANAL RECTAL RESECTION FOR THE SURGICAL TREATMENT OF OBSTRUCTED DEFECATION SYNDROME ASSOCIATED WITH RECTOCELE AND RECTAL INTUSSUSCEPTION". AUTHORS: HESHAM M. HASAN AND HANI M. HASAN. CITATION: INTERNATIONAL SCHOLARLY RESEARCH NETWORK ISRN SURGERY VOLUME 2012, ARTICLE ID 652345, 6 PAGES; DOI: 10.5402/2012/652345. THIS PROSPECTIVE CLINICAL STUDY AIMED TO PRESENT PRELIMINARY RESULTS WITH STARR OPERATION FOR THE TREATMENT OF OBSTRUCTIVE DEFECATION SYNDROME DUE TO RI AND RE. BETWEEN MAY 2008 TO OCTOBER 2010, 40 FEMALE PATIENTS (MEDIAN AGE 45.7 ± 12.3 YEARS; RANGE 30-63 YEARS) WITH ODS CAUSED BY RECTAL INTUSSUSCEPTION (RI) AND/OR RECTOCELE (RE) HAD STARR. TWO CIRCULAR PPH-01 STAPLERS (ETHICON ENDO-SURGERY, INC., USA) WERE USED. THE FIRST PPH01 STAPLER WAS INSERTED, AND THE POSTERIOR RECTAL WALL WAS PROTECTED WITH A SPATULA. THE ENDS OF SUTURES WERE DELIVERED THROUGH THE SPECIFIC HOLES OF THE STAPLER, AND TENSION WAS APPLIED TO PROLAPSE THE REMOVED TISSUES INTO THE STAPLER HOUSING, MAKING SURE THAT THE POSTERIOR VAGINAL WALL HAD NOT BEEN INCORPORATED; THE STAPLER WAS CLOSED AND FIRED. BY THE SAME PROCEDURE, TWO SEMI-CIRCUMFERENTIAL PURSE-STRING SUTURES AND A SECOND PPH-01 STAPLER WERE PERFORMED ON THE POSTERIOR RECTAL WALL (FIGURES 4 AND 5). HEMOSTATIC STITCHES WITH FULL-THICKNESS 2-0 VICRYL STITCHES WERE USED TO CONTROL BLEEDING FROM STAPLES LINE. COMPLICATIONS INCLUDED INTRAOPERATIVE BLEEDING FROM ANASTOMOTIC RING (N=80%) WHICH WAS SECURED WITH HEMOSTATIC STITCHES; DEFECATORY URGENCY AT FIRST WEEK (N=16) , AFTER 3 MONTHS (N=4), AFTER 6 MONTHS (N=2) AND AFTER 12 MONTHS (N=1); POSTOPERATIVE BLEEDING AT FIRST WEEK (N=4) WHICH STOPPED SPONTANEOUSLY WITH CONSERVATIVE TREATMENT WITH NO FURTHER SURGICAL INTERVENTION REQUIRED AND PAIN AT FIRST WEEK (N=4), AFTER 3 MONTHS (N=2) AND AFTER 6 MONTHS (N=1). IN CONCLUSION, STARR IS AN EFFECTIVE AND SAFE PROCEDURE FOR THE TREATMENT OF OBSTRUCTED DEFECATION SYNDROME DUE TO RECTAL INTUSSUSCEPTION AND/OR RECTOCELE AND CAN BE PERFORMED SAFELY WITHOUT MAJOR MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565053 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention