BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 7742621 · Received August 2, 2018

    Report

    Report Number
    3005075853-2018-11808
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    July 9, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036002878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY PUBLICATION YEAR (2014) IS KNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: LONG-TERM RESULTS FOLLOWING TRANSANAL RECTAL RESECTION IN PATIENTS WITH OBSTRUCTED DEFECATION SYNDROME AUTHOR: R. PROSST. CITATION: COLOPROCTOLOGY 2014 36:54¿55, DOI 10.1007/S00053-013-0428-3; PUBLISHED ONLINE: 15/01/2014. THE GOAL OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE THE FUNCTIONAL LONG-TERM RESULTS AND QUALITY OF LIFE FOLLOWING TRANSTAR PROCEDURE SURGERY. THE 77 CONSECUTIVE PATIENTS (68 FEMALE) WITH OBSTRUCTED DEFECATION SYNDROME AVERAGED 65 YEARS OF AGE (20-90 YRS.) WERE INCLUDED IN THE STUDY. THE TRANSTAR OPERATIONS OCCURRED BETWEEN JANUARY 2007 AND MARCH 2010. CONTOUR TRANSTAR PROCEDURE ALLOWS ACHIEVEMENT OF A SIGNIFICANTLY LARGER RESECTION THAN THE STARR PROCEDURE, DUE TO BETTER INTRA-OPERATIVE VIEW AND MONITORING. HOWEVER, THIS DID NOT RESULT IN ANY VERIFIABLE CLINICALLY FUNCTIONAL IMPROVEMENT, AT LEAST WITHIN A BRIEF FOLLOW-UP OBSERVATION PERIOD. NINE PATIENTS REPORTED NEWLY OCCURRING POST-OPERATIVE INCONTINENCE FOR WHICH ADDITIONAL TREATMENT WAS REQUIRED. THIS VERIFIES THAT THE INCONTINENCE FREQUENTLY ASSOCIATED WITH A RECTAL PROLAPSE SHOULD NOT BE VIEWED AS A SURGICAL CONTRAINDICATION BUT CONTINENT PATIENTS SHOULD BE NOTIFIED OF THE POSSIBILITY OF INCONTINENCE FOLLOWING THE TRANSTAR PROCEDURE. IN CONCLUSION, THE TRANSTAR PROCEDURE WAS EMPLOYED SUCCESSFULLY FOR LONG-TERM TREATMENT OF OBSTRUCTED DEFECATION SYNDROME. DEFECATION URGE AND INCONTINENCE WERE OBSERVED, HOWEVER, THIS USUALLY IMPROVED WITHIN MONTHS. THEREFORE, THE TRANSTAR PROCEDURE APPEARS TO BE A SENSIBLE APPROACH TO THE TREATMENT OF OBSTRUCTED DEFECATION SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585061 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention