BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 33MM, CURVED

    MDR report key: 9967244 · Received April 16, 2020

    Report

    Report Number
    3005075853-2020-02189
    Event Type
    Injury
    Date Received
    April 16, 2020
    Report Date
    June 24, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/24/2025. CORRECTED DATA: D1, D4. H6: HEALTH EFFECT ¿ CLINICAL CODE GASTROINTESTINAL SYSTEM (E10).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: CLINICAL ASSESSMENT OF SHORT-TERM OUTCOME OF SPHINCTER-SPARING SURGERY IN PATIENTS WITH LOW RECTAL CARCINOMA. AUTHORS: EMAD HOKKAMA; MOHAMED FAISAL; MOHAMED SHAMS; AHMED GOMAA; HAMADA FATHEY. CITATION: EGYPTIAN J SURGERY 38:250¿256; DOI: 10.4103/EJS.EJS_185_18. THE AIM OF THIS PROSPECTIVE STUDY IS TO EVALUATE EARLY OUTCOME OF SPHINCTER-SPARING SURGERY IN PATIENTS WITH LOW RECTAL CANCER. BETWEEN FEBRUARY 2014 AND JANUARY 2017, 153 PATIENTS WITH PROVEN ENDOSCOPIC BIOPSY FOR PRIMARY LOW RECTAL CARCINOMA WERE ENROLLED IN THE STUDY. DURING THE PROCEDURE, THE SIGMOID COLON WAS DIVIDED PROXIMALLY, AND THE RECTUM WAS RESECTED WITH DISTAL SAFETY MARGIN OF AT LEAST 1.5 CM WITH THE HELP OF ETHICON CONTOUR CURVED CUTTER STAPLER (ETHICON) TO CLOSE THE DISTAL STUMP. WHENEVER POSSIBLE, THE ANASTOMOSIS WAS ESTABLISHED THROUGH THE ABDOMEN USING THE ETHICON CIRCULAR STAPLERS (ECSA-29 AND ECSA-33 STAPLER; ETHICON) ACCORDING TO THE DIAMETER OF RECTUM AND SEX OF THE PATIENT. REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAK (N=6) IN WHICH HALF OF THEM WERE MANAGED BY REPAIRING AND SAVING THE ANASTOMOSIS WHEREAS THE OTHER HALF WERE MANAGED BY DEFINITIVE COLOSTOMY; PELVIC ABSCESS (N=7) WHICH WAS TREATED BY ULTRASOUND-GUIDED DRAINAGE; ANASTOMOTIC STENOSIS (N=18) TREATED BY MANUAL DILATION; GRADE II INCONTINENCE (N=16); GRADE III INCONTINENCE (N=8); GRADE IV INCONTINENCE (N=2). IN CONCLUSION, SPHINCTER-SPARING SURGERY FOR LOW RECTAL CARCINOMA IS A GOOD OPTION TO AVOID PERMANENT STOMA WITH ITS ASSOCIATED MORBIDITY AND SOCIAL AND PSYCHIC EFFECTS. IT HAS ACCEPTED ONCOLOGICAL AND FUNCTIONAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431695 ILS 33MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention