BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 7666045 · Received July 6, 2018

    Report

    Report Number
    3005075853-2018-11137
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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: THE EVOLUTION OF TRANSANAL SURGERY FOR OBSTRUCTED DEFECATION SYNDROME: MID-TERM RESULTS FROM A RANDOMIZED STUDY COMPARING DOUBLE TST 36 HV AND CONTOUR TRANSTAR STAPLERS. AUTHORS: PAOLO BOCCASANTA, SERGIO AGRADI, CONTARDO VERGANI, GIUSEPPE CALABRO, LUCA BORDONI, CLAUDIO MISSAGLIA, AND MARCO VENTURI. CITATION: THE AMERICAN JOURNAL OF SURGERY XXX (2018) 1-7; HTTPS://DOI.ORG/10.1016/J.AMJSURG.2018.01.074. THE AIM OF THIS RANDOMIZED STUDY WAS TO COMPARE THE MEDIUM-TERM CLINICAL AND FUNCTIONAL RESULTS OF CCS 30 AND TWO H-V 36 STAPLERS IN TWO HOMOGENEOUS GROUPS OF PATIENTS WITH OBSTRUCTED DEFECATION SYNDROME, CAUSED BY INTERNAL RECTAL PROLAPSE (OR INTUSSUSCEPTION) AND RECTOCELE, WITH COMPLICATION RATE AS PRIMARY OUTCOME MEASURE. BETWEEN THE PERIODS OF JANUARY 2014 TO MAY 2016, OUT OF 297 WOMEN WITH ODS, 208 (MEAN AGE 55.9 YEARS, RANGE 27E77) WERE SELECTED AND WAS INCLUDED IN THE STUDY. WITH CLINICAL EXAMINATION, CONSTIPATION SCORE, COLONOSCOPY, ANORECTAL MANOMETRY, AND PERINEORRHAPHY AND RANDOMLY ASSIGNED TO 2 GROUPS: 104 PATIENTS (MEAN AGE 54.8 YEARS, RANGE 27-77) UNDERWENT STAPLED TRANSANAL RECTAL RESECTION WITH CURVED MULTIFIRE STAPLER (TRANSTAR GROUP) AND 104 (MEAN AGE 57.1 YEARS, RANGE 31-74) HAD THE SAME OPERATION WITH TWO CIRCULAR TST36 STAPLERS (DOUBLE STARR PLUS GROUP). DURING THE PROCEDURE IN TRANSTAR, AFTER POSITIONING THE DILATOR CAD38, AND APPLYING 4 SUTURES TO THE PROLAPSED TISSUE, THE CCS-30 CONTOUR R TRANSTAR ¿ (ETHICON-ENDOSURGERY, INC, POMEZIA, ITALY) CURVED STAPLER WAS PLACED IN THE 3 O'CLOCK POSITION AND FIRED, IN ORDER TO CREATE A RADIAL SECTION LINE IN THE RECTAL WALL. IN DOUBLE STARR PLUS, THE 2-WINDOWS 36MM ANAL DILATOR WAS INTRODUCED IN THE ANAL CANAL AND FIXED WITH 4 2-0 SILK STITCHES TO THE SKIN. THE PARACHUTE TECHNIQUE WITH 4 PROLENE 2-0 RUNNING SUTURE AT 2, 5, 7, 10 O'CLOCK WAS USED, ALLOWING A SYMMETRICAL TRACTION OF THE MAXIMUM AMOUNT OF TISSUE CONSENTED BY THE HOUSE STAPLING. THEN THE FIRST TST 36 HV STAPLER WAS POSITIONED CLOSED AND THE STAPLES FIRED. CUMULATIVE COMPLICATION RATE WAS 13.5% (9 BLEEDING, 3 ACUTE URINARY RETENTION, 1 ANASTOMOTIC DEHISCENCE, 1 TEAR OF THE VAGINA) IN TRANSTAR GROUP AND 4.8% (3 BLEEDING, 2 SUTURE LINE LEAKAGES) WITH DOUBLE STARR PLUS (P= 0.019). THE VAGINAL LESION, CAUSED BY ENTRAPPING THE VAGINAL WALL IN THE STAPLER DEVICE, WAS FOUND AT THE END OF THE OPERATION, WAS LOCATED ON THE POSTERIOR VAGINAL WALL, WITH A DIAMETER OF 6 MM, AND WAS DIRECTLY REPAIRED WITH 3-0 ABSORBABLE STITCHES, WITH NO AFTER-EFFECTS. THE ANASTOMOTIC DEHISCENCE REQUIRED A REOPERATION, WHILE STAPLE LINE LEAKAGES WHERE DIRECTLY SUTURED DURING THE OPERATION. THE POSTOPERATIVE BLEEDINGS WERE SELF-LIMITATING AND TREATED CONSERVATIVELY, AVOIDING ADDITIONAL OPERATIONS. TWO PATIENTS WITH ACUTE URINARY RETENTION REQUIRED SHORT-TERM URINARY CATHETERIZATION. IN CONCLUSION, IN PATIENTS WITH THIRD GRADE RECTAL PROLAPSE AND RECTOCELE DEEPER THAN 5 CM, THE DOUBLE STARR PLUS APPEARS TO BE THE BEST ALTERNATIVE TO THE TRANSTAR TECHNIQUE, CONSENTING TO OBTAIN THE SAME MIDTERM CLINICAL AND FUNCTIONAL RESULTS WITH LESS COMPLICATIONS AND MONEY SAVING. LONGER FOLLOW UP IS NECESSARY TO ASSESS IS THE NOT SIGNIFICANT GAP IN THE RECURRENCE RATE WILL REACH THE SIGNIFICANCE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509449 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention