BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 7666476 · Received July 6, 2018

    Report

    Report Number
    3005075853-2018-11143
    Event Type
    Injury
    Date Received
    July 6, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036002878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. 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 ARTICLE ENTITLED: LONG-TERM OUTCOME AFTER TRANSANAL RECTAL RESECTION IN PATIENTS WITH OBSTRUCTED. DEFECATION SYNDROME. AUTHOR : SUSANNE BOCK1 ¿ KATJA WOLFF, M.D.1 ¿ LUKAS MARTI, M.D.1. BRUNO M. SCHMIED, M.D.1 ¿ FRANC H. HETZER, M.D.2. CITATION: DIS COLON RECTUM 2013; 56: 246¿252; DOI: 10.1097/DCR.0B013E31827619AA. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE LONG-TERM FUNCTIONAL RESULTS AND QUALITY OF LIFE AFTER THE TRANSTAR PROCEDURE. BETWEEN JANUARY 2007 TO MARCH 2010, 70 PATIENTS (68 FEMALES) WITH OBSTRUCTED DEFECATION SYNDROME (ODS) HAD A MEDIAN AGE OF 65 YEARS (RANGE, 20¿90) WERE INCLUDED IN THE STUDY. CCS CONTOUR TRANSTAR (ETHICON ENDO-SURGERY, CINCINNATI, OH) WAS USED IN THE TRANSTAR PROCEDURE. THERE WERE 16 PATIENTS WITH INCONTINENCE AFTER THE PROCEDURE, 7 HAD PREEXISTING INCONTINENCE AND 9 (13%) HAD NEWLY ACQUIRED INCONTINENCE. OF THESE 16 PATIENTS, 8 ACHIEVED CONTINENCE WITH MEDICINAL SUPPORT WITHIN THE FIRST POSTOPERATIVE MONTHS. OF THE PATIENTS THAT REMAINED INCONTINENT, 6 HAD PREOPERATIVELY UNDETECTABLE PATHOLOGIES THAT WERE FOUND POSTOPERATIVELY TO BE THE PROBABLE CAUSE OF INCONTINENCE. OF THESE, 4 ACHIEVED CONTINENCE AFTER AN ADDITIONAL SURGERY: 2 HAD A SPHINCTER REPAIR, 1 HAD A SACRAL NEUROMODULATION, AND 1 UNDERWENT A COLPORECTOSACROPEXY. THE OTHER 2 PATIENTS, ONE AFTER AN UNSUCCESSFUL SACRAL NEUROMODULATION TEST, DECIDED NOT TO HAVE FURTHER TREATMENT. THERE WERE SEVERAL OTHER MINOR COMPLICATIONS. IN PARTICULAR, WE OBSERVED 1 HEMORRHOIDAL CONDITION, 1 SMALL ANASTOMOTIC ULCER, 2 PERIANAL VENOUS THROMBOSES, 1 ANAL FISSURE, 1 SMALL BLEEDING, 1 PROLONGED URINARY RETENTION, AND 1 CYSTITIS. ALL THESE CONDITIONS WERE CURED BY MEDICINAL TREATMENT OR A MINOR INTERVENTION. IN SUMMARY, 13 (19%) COMPLICATIONS REQUIRED INTERVENTION WITHOUT GENERAL ANESTHESIA AND 7 (10%) COMPLICATIONS REQUIRED SURGERY UNDER GENERAL ANESTHESIA. NO COMPLICATIONS OF HIGHER GRADE (EG, INTENSIVE CARE UNIT, DEATH) WERE OBSERVED. IN CONCLUSION, TRANSTAR IS AN EFFICACIOUS METHOD FOR THE TREATMENT OF ODS ALSO OVER THE LONG TERM. OUTCOME, AND MORBIDITY AND RECURRENCE, AS WELL, ARE SIMILAR TO THOSE REPORTED FOR STA RR IN THE LITERATURE. THEREFORE, TRANSTAR APPEARS TO BE A REASONABLE APPROACH TO TREATING ODS IN THE LONG TERM. THE SIGNIFICANCE OF AN INDIVIDUAL, PROLAPSED-TAILORED TREATMENT OF ODS WITH EITHER STA RR OR TRANSTAR REMAINS SUBJECT TO FURTHER STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508315 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention