BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 7727803 · Received July 27, 2018

    Report

    Report Number
    3005075853-2018-11623
    Event Type
    Injury
    Date Received
    July 27, 2018
    Report Date
    July 2, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036002878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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: OUTCOME AFTER STAPLED PERINEAL RECTOSIGMOIDECTOMY USING TRANSTARR. AUTHOR : LIESKE B., CONAGHAN P., FAROUK R. CITATION: DISEASES OF THE COLON AND RECTUM. 2010; 53(4): 592. DOI: HTTP://DX.DOI.ORG/10.1097/01.DCR. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE IMMEDIATE AND SHORT TERM OUTCOMES AFTER TRANSTARR ASSISTED PERINEAL RECTOSIGMOIDECTOMY. A TOTAL OF 20 CONSECUTIVE WOMEN (AGE RANGE: 41 TO 96 YEARS OLD) WHO PRESENTED WITH A FULL THICKNESS RECTAL PROLAPSE UNDERWENT STAPLED PERINEAL RECTOSIGMOIDECTOMY BETWEEN JULY 2008 AND NOVEMBER 2008. DURING THE SURGICAL PROCEDURE, TRANSTARR STAPLED PERINEAL RECTOSIGMOIDECTOMY IS PERFORMED BY PLACING THE PATIENT IN LITHOTOMY AND THE RECTAL PROLAPSE DELIVERED EXTERNALLY. THE RECTUM IS DIVIDED LONGITUDINALLY AT THE 3 AND 9 O'CLOCK POSITIONS WITH A LINEAR STAPLER EFFECTIVELY CREATING ANTERIOR AND POSTERIOR FULL THICKNESS RECTAL FLAPS. THE FLAPS ARE THEN TRANSECTED TRANSVERSELY ONE CENTIMETER ABOVE THE DENTATE LINE WITH THE TRANSTARR STAPLER (ETHICON). REPORTED COMPLICATIONS INCLUDED RECTAL BLEEDING (N-2), HEMORRHOIDS (N-1) WHICH WAS GIVEN UNSPECIFIED TREATMENT, AND DIVERTICULAR RELATED BLEEDING (N-1) WHICH WAS GIVEN UNSPECIFIED TREATMENT. IT WAS CONCLUDED THAT THE TRANSTARR STAPLED PERINEAL RECTOSIGMOIDECTOMY OFFERS A SAFE PERINEAL SURGICAL OPTION FOR PATIENTS WITH FULL THICKNESS RECTAL PROLAPSE IN WHOM AN ABDOMINAL PROCEDURE IS NOT AN OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567313 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention