BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 7735417 · Received July 31, 2018

    Report

    Report Number
    3005075853-2018-11728
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    July 4, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: SINGLE VERSUS DOUBLE STAPLING ANASTOMOTIC TECHNIQUE IN RECTAL CANCER SURGERY. AUTHOR : Z. RADOVANOVIC ¿ T. PETROVIC ¿ D. RADOVANOVIC ¿ M. BREBERINA ¿ A. GOLUBOVIC ¿ D. LUKIC. CITATION: SURG TODAY (2014) 44:1026¿1031; DOI 10.1007/S00595-013-0646-X. THE STUDY AIMED TO INVESTIGATE WHETHER THERE IS A DIFFERENCE IN THE ANASTOMOTIC LEAKAGE (AL) RATE BETWEEN THE SINGLE STAPLING (CSA) AND DOUBLE STAPLING (DSA) ANASTOMOTIC TECHNIQUES. BETWEEN JUN 2007 AND DEC 2009, 100 PATIENTS WITH RECTAL CANCER UNDERWENT RECTAL RESECTION WITH PRIMARY ANASTOMOSIS AND WERE RANDOMLY DIVIDED TO CSA GROUP (N=50; N=31 MALE AND N=19 FEMALE; MEAN AGE OF 66 YEARS [RANGED 39-88 YEARS]) AND DSA GROUP (N=50; N=26 MALE AND N=24 FEMALE; MEAN AGE OF 64 YEARS [RANGED 39-80 YEARS]). IN THE DSA GROUP, THE RECTAL STUMP WAS CLOSE USING CONTOUR CURVED CUTTER STAPLER AND ANASTOMOSIS WAS CREATED USING CIRCULAR STAPLER. POSTOPERATIVELY, IN DRA GROUP, INCOMPLETE ANASTOMOSIS AND/OR POSITIVE AIR TEST WAS OBSERVED IN 3 PATIENTS FOR WHICH ADDITIONAL HAND SUTURE WAS REQUIRED. FOUR PATIENTS FROM THIS GROUP EXPERIENCED CLINICAL ANASTOMOTIC LEAKS WITH ONE PATIENT REQUIRING REOPERATION AND THE REMAINING THREE RECOVERING WITH CONSERVATIVE TREATMENT. THE CSA AND DSA TECHNIQUES ARE EQUALLY SAFE FOR THE CREATION OF A RECTAL ANASTOMOSIS, WITHOUT ANY SIGNIFICANT DIFFERENCE IN THE AL RATE. THE AUTHORS RECOMMENDED THE USE THE DSA TECHNIQUE BECAUSE IT HAS DEFINITE ADVANTAGES, SUCH AS A SHORTER OPERATION, MINIMIZED CONTAMINATION, A LOWER RATE OF COVERING COLOSTOMY AND THE ABILITY TO CREATE A VERY LOW ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578512 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention