BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 7734642 · Received July 31, 2018

    Report

    Report Number
    3005075853-2018-11710
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036002878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: RESECTED SPECIMEN EVALUATION, ANORECTAL MANOMETRY, ENDOANAL ULTRASONOGRAPHY AND CLINICAL FOLLOW-UP AFTER STARR PROCEDURES AUTHORS: GABRIELE NALDINI, GUIDO CERULLO, CLAUDIA MENCONI, JACOPO MARTELLUCCI, SIMONE ORLANDI, NICOLA ROMANO AND MAURO ROSSI CITATION: WORLD J GASTROENTEROL 2011 MAY 21; 17(19): 2411-2416; DOI:10.3748/WJG.V17.I19.2411 THE PURPOSE OF THIS STUDY WAS INVESTIGATE THE STAPLED TRANSANAL RECTAL RESECTION (STARR) PROCEDURES AS SURGICAL TECHNIQUES FOR OBSTRUCTED DEFECATION SYNDROME (ODS) BY ANALYZING SPECIMEN EVALUATION, ANORECTAL MANOMETRY, ENDOANAL ULTRASONOGRAPHY AND CLINICAL FOLLOW-UP AND TO COMPARE THE SPECIMEN FEATURES OBTAINED USING THE TRADITIONAL TWO STAPLERS TECHNIQUE (STARR) WITH CONTOUR CCS 30 (TRANSTAR), AND TO EVALUATE THE EARLY AND LATE POSTOPERATIVE OUTCOME. FROM JANUARY TO DECEMBER 2007, WE HAVE TREATED 30 PATIENTS (ALL FEMALES). FIFTEEN TREATED WITH DOUBLE PPH-01 STAPLERS AND 15 TREATED USING NEW CCS 30 CONTOUR. PPH-STARR WAS PERFORMED USING TWO PPH 01-STAPLING DEVICES (ETHICON ENDO-SURGERY, CINCINNATI, USA) AS DESCRIBED ELSEWHERE. IN ADDITION, 2/0 VICRYL SUTURES WERE USED TO OVERSEW THE STAPLE LINE IN ORDER TO REDUCE POSTOPERATIVE BLEEDING. FOR THE CONTOUR TRANSTAR-PROCEDURE, A CCS-30 STAPLER KIT (ETHICON ENDO-SURGERY, CINCINNATI, USA) WAS USED. THE INTERNAL PROLAPSE IS VERIFIED BY INSERTION AND WITHDRAWAL OF A GAUZE SWAB. STARTING AT THE 2 O¿CLOCK POSITION, A 2/0 VICRYL TRACTION SUTURE IS PLACED AT THE APEX OF THE PROLAPSE. THE CONTOUR TRANSTAR DEVICE IS INTRODUCED INTO THE RECTUM AND THE PROLAPSE AT THE 3 O¿CLOCK POSITION AND PULLED INTO THE JAWS USING THE PREVIOUSLY PLACED TRACTION SUTURE AND MARKING SUTURE. IN ORDER TO SECURE HAEMOSTASIS, SINGLE 2/0 VICRYL STITCHES WERE USED TO UNDER-RUN THE STAPLE LINE. FINALLY AN EASY-FLOW-DRAINAGE IS PLACED IN THE ANUS AS AN INDICATOR OF BLEEDING. ONLY ONE COMPLICATION, ACUTE BLEEDING, OCCURRED IN THE CCS 30 GROUP (3.3%), PROMPTLY TREATED WITH SURGERY IN ORDER TO CONTROL THE BLEEDING. IN CONCLUSION, IN OUR EXPERIENCE STARR WITH CONTOUR CCS 30 IS A SAFE AND FEASIBLE TECHNIQUE ALLOWING THE EXCISION OF A MAJOR AMOUNT OF TISSUE WITHOUT ANY INCREASING OF THE EARLY COMPLICATION RATE OR SPHINCTER INJURIES, AS DEMONSTRATED BY THE ENDOANAL ULTRASONOGRAPHY. FURTHER STUDIES SHOULD INVESTIGATE LONGER CLINICAL OUTCOMES AND ALLOW US TO EVALUATE IF A LARGER RECTAL RESECTION RESULTS IN A FUNCTIONAL IMPROVEMENT EMPHASIZING THE REAL ADVANTAGES OF CCS 30 WITH RESPECT TO STARR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579173 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention