BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 7720708 · Received July 25, 2018

    Report

    Report Number
    3005075853-2018-11550
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    January 1, 2007
    Report Date
    June 28, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036002878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: STAPLED TRANSANAL RECTAL RESECTION WITH THE CCS-30 CONTOUR TRANSTAR FOR OBSTRUCTIVE DEFECATION SYNDROME AND RECTOCELE: A LONG TERM FOLLOW UP.. AUTHOR : GIARRATANO G.; GHINI C.; MAZZI M.; TOSCANA C.; SILERI P.; STAZI A. WEB ADDRESS: DOI: HTTP://DX.DOI.ORG/10.1007/S10151 CITATION: TECHNIQUES IN COLOPROCTOLOGY. CONFERENCE: 5TH NATIONAL CONGRESS OF THE ITALIAN SOCIETY OF COLORECTAL SURGERY: FROM PERSONAL OPINIONS TO EVIDENCE-BASED SURGERY. LECCE ITALY. CONFERENCE PUBLICATION: (VAR.PAGINGS). 18 (1) (PP 98), 2014. DATE OF PUBLICATION: JANUARY 2014. THE STUDY AIMED TO EVLAUTE THE LONG-TERM OUTCOME OF PATIENTS WHO UNDERWENT STAPLED TRANSANAL RECTAL RESECTION WITH THE CCS-30 CONTOUR TRANSTAR FOR OBSTRUCTIVE DEFECATION SYNDROME (ODS) AND/OR RECTOCELE. FROM JAN2007 TO JAN2009, 90 PATIENTS WITH ODS CAUSED BY RECTAL INTUSSUSCEPTION AND RECTOCELE UNDERWENT STAPLED TRANSANAL RECTAL RESECTION WITH THE CCS-30 CONTOUR TRANSTAR DEVICE. ON THE MEDIAN FOLLOW-UP PERIOD OF 50 MONTHS, MINOR COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING. MAJOR COMPLICATIONS INCLUDED ANTERIOR-LATERAL DEHISCENCE TREATED WITH A TEMPORARY STOMA; STAPLES RETAINED IN THE PUBORECTALIS MUSCLE THAT REQUIRED REMOVAL OF THE ENTIRE SUTURE, AND RECURRENCES (N=3). STAPLED TRANSANAL RECTAL RESECTION WITH THE CCS-30 CONTOUR TRANSTAR IS A SAFE AND EFFECTIVE PROCEDURE IN A WELL-TRAINED SURGEONS WITH HIGH SATISFACTORY RATE AND LOW RATE OF RECURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560592 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention