BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 7727727 · Received July 27, 2018

    Report

    Report Number
    3005075853-2018-11615
    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 Location
    IT
    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: STAPLED TRANSANAL RECTAL RESECTION WITH CONTOUR TRANSTAR FOR OBSTRUCTED DEFECATION SYNDROME: LESSONS LEARNED AFTER MORE THAN 3 YEARS OF SINGLE-CENTER ACTIVITY AUTHOR : MASONI LUIGI, M.D. , MARI FRANCESCO SAVERIO, M.D. , FAVI FRANCESCO, M.D. MARCELLO GASPARRINI, M.D. ¿ COSENZA UMILE MICHELE, M.D. ¿ PINDOZZI FIORALBA, M.D. PANCALDI ALESSANDRA, M.D. ¿ BRESCIA ANTONIO, M.D CITATION: DIS COLON RECTUM 2013; 56: 113¿119. DOI: 10.1097/DCR.0B013E31826BDA94. THE OBJECTIVES OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF THE STAPLED TRANSANAL RECTAL RESECTION (STARR) PERFORMED WITH A NEW DEDICATED CURVED DEVICE IN THE TREATMENT OF OBSTRUCTED DEFECATION SYNDROME (ODS). A TOTAL OF 187 STAPLED TRANSANAL RECTAL RESECTIONS (182 WOMEN AND 5 MEN; AGE RANGE: 33 TO 85 YEARS OLD; BMI: RANGE, 21¿33 KG/M2) WERE PERFORMED FROM JUNE 2007 TO FEBRUARY 2011 WAS CONDUCTED. DURING THE SURGICAL PROCEDURE, ALL PATIENTS UNDERWENT STARR PROCEDURE WITH CCS-30 STAPLING DEVICE (ETHICON). THE LONGITUDINAL OPENING THEN ALLOWS THE SURGEON TO BEGIN CIRCUMFERENTIAL RESECTION OF THE RECTUM BY PULLING ON THE PARACHUTE STITCHES. THIS MANEUVER IS PERFORMED COUNTERCLOCKWISE WITH THE USE OF AN AVERAGE OF 4 TO 6 RECHARGES, WITH CARE TO ALWAYS PLACE THE STAPLER AT THE BASE OF THE PROLAPSE. AT THE END OF THE PROCEDURE, IT IS HELPFUL TO PLACE SOME STITCHES ON THE STAPLE LINE TO CONTROL EVENTUAL ANASTOMOTIC BLEEDING AND AT THE BEGINNING AND END OF THE RESECTION TO AVOID DOG EARS. REPORTED COMPLICATIONS INCLUDED SPIRALING OF STAPLE LINE (N-9) WHICH RESOLVED WITHIN 3 MONTHS AFTER SURGERY, PERI-ANAL HEMATOMA (N-4), AND RECTOVAGINAL FISTULA (N-1) WHICH WAS TREATED BY REPAIRING THE RECTAL WALL WITH ADVANCEMENT FLAP AND DID NOT REQUIRE THE CREATION OF A PROTECTIVE STOMA. AT 1 MONTH POST-SURGERY COMPLICATIONS INCLUDED TENESMUS (N-35), URGENCY (N-17), AND FRAGMENTED EVACUATION (N-12) WHICH REQUIRED PELVIC FLOOR REHABILITATION. AT 3 MONTHS POST-SURGERY, COMPLICATIONS INCLUDED TENESMUS (N-11), URGENCY (N-9), AND FRAGMENTED EVACUATION (N-5) WHICH REQUIRED PELVIC FLOOR REHABILITATION. AT 6 MONTHS POST-SURGERY COMPLICATIONS INCLUDED TENESMUS (N-2), URGENCY (N-2), AND FRAGMENTED EVACUATION (N-2) WHICH REQUIRED PELVIC FLOOR REHABILITATION. IT WAS CONCLUDED THAT THE RESULTS OF THIS STUDY SHOW THAT THE STAPLED TRANSANAL RECTAL RESECTION PERFORMED WITH THE USE OF THE CONTOUR TRANSTAR STAPLING DEVICE IS A SAFE AND EFFECTIVE PROCEDURE TO TREAT OBSTRUCTED DEFECATION SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568983 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention