BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM, CURVED

    MDR report key: 7724081 · Received July 26, 2018

    Report

    Report Number
    3005075853-2018-11586
    Event Type
    Injury
    Date Received
    July 26, 2018
    Report Date
    June 29, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036003462
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ARTICLE ENTITLED: CURVED CUTTER STAPLER VS. LINEAR STAPLER IN RECTAL CANCER SURGERY: A PILOT PROSPECTIVE RANDOMIZED STUDY AUTHOR : WON-SUK LEE , WOO YONG LEE , HO-KYUNG CHUN , SEONG HYEON YUN , YONG BEOM CHO , HAE-RAN YUN, CITATION: INT J COLORECTAL DIS (2009) 24:1327¿1332; DOI 10.1007/S00384-009-0771-6 THE STUDY AIMED TO COMPARE THE SAFETY AND TECHNICAL ACCESSIBILITY OF LINEAR STAPLER AND CURVED CUTTER STAPLER (CCS DURING MID TO LOW RECTAL CANCER SURGERY. BETWEEN APR2006 AND NOV2006, 60 PATIENTS WITH MID TO LOW RECTAL ADENOCARCINOMA UNDERWENT LOW ANTERIOR RESECTION AND WERE RANDOMLY ASSIGNED TO EITHER LINEAR STAPLERS (N=30; N=21 MALE AND N=9 FEMALE; MEAN AGE SD OF 60.1±11.8 YEARS) OR CONTOUR CURVED CUTTER STAPLER (CCS) (N=30; N=20 MALE AND N=10 FEMALE; MEAN AGE SD OF 54.9±11.4 YEARS). ALL PATIENTS UNDERWENT STRAIGHT END-TO-END ANASTOMOSIS. THE CIRCULAR STAPLER (CDH 29MM - ETHICON) WAS INSERTED TRANSANALLY AND FIRED. IN CCS GROUP, DISTAL RECTUM WAS SECURED USING CCS. POSTOPERATIVELY IN CCS GROUP, COMPLICATIONS INCLUDED SPONTANEOUS ANASTOMOTIC BLEEDING (N=3), POSITIVE BACTERIAL CULTURE (N=1), INTERPERITONEAL LEAKAGE FOLLOWING DEHISCENCE OF ANASTOMOSIS (N=3), VAGINAL PINCHING/ENTRAPMENT OF VAGINA (N=3) AND WOUND COMPLICATION (N=5). IN LINEAR STAPLER GROUP, COMPLICATIONS INCLUDED ANASTOMOTIC BLEEDING (N=3), POSITIVE BACTERIAL CULTURE (N=6), ANASTOMOTIC LEAKAGE (N=2) AND WOUND COMPLICATION (N=5). IT IS DIFFICULT TO DETERMINE WHETHER THE STAPLING DEVICE ITSELF OR OTHER CONFOUNDING VARIABLES CONTRIBUTED TO THE LEAKAGE. IN THIS STUDY, BOTH THE CCS AND LINEAR STAPLERS WERE SATISFACTORY DEVICES FOR SECURING THE DISTAL RECTUM DURING LOW ANTERIOR RESECTION IN MID TO LOW RECTAL CANCERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563650 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036003462

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention