BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 22371305 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04880
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    March 30, 2020
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 7/1/2025. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. H6: HEALTH EFFECT ¿ CLINICAL CODE GASTROINTESTINAL SYSTEM (E10). D4: BATCH # UNK. B3: UNKNOWN; CAPTURED AS AWARENESS DATE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    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
    1261804 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention