BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 14336144 · Received May 9, 2022

    Report

    Report Number
    3005075853-2022-02950
    Event Type
    Death
    Date Received
    May 9, 2022
    Date of Event
    January 7, 2022
    Report Date
    May 9, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNKNOWN. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THERE WAS AN ALLEGED DEFICIENCY OF THE ETHICON CONTOUR, ECHELON FLEX STAPLER OR CDH33 DEVICE THAT CONTRIBUTED TO THE DEATH OR ANY OF THE REPORTED ISSUES OR WERE THERE OTHER CONTRIBUTING PATIENT FACTORS?

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: TAILORED MANAGEMENT WITH HIGHLY-SELECTIVE DIVERSION FOR LOW COLORECTAL ANASTOMOSIS: BIOCHEMICAL POSTOPERATIVE FOLLOW-UP AND LONG-TERM RESULTS FROM A SINGLE-INSTITUTION COHORT. AUTHORS: PHILIPPE ROUANET, MD, PHD, MARIE SELVY, MD, MARTA JARLIER, MSC, CAROLINE BUGNON, MD, GUILLAUME CARRIER, MD, ANNE MOURREGOT, MD, PIERRE-EMMANUEL COLOMBO, MD, PHD, AND CHRISTOPHE TAOUM, MD. CITATION CITE: ANN SURG ONCOL (2022) 29:2514¿2524 HTTPS://DOI.ORG/10.1245/S10434-021-11197-2. ALL CONSECUTIVE PATIENTS WHO UNDERWENT LCRA FOR MIDDLE- OR LOWER-THIRD RECTAL ADENOCARCINOMA WITH CURATIVE INTENT FROM JANUARY 2010 TO DECEMBER 2017 WERE IDENTIFIED, WITH PERMISSION, FROM OUR PROSPECTIVE, SINGLE-CENTER, INSTITUTIONAL DATABASE. IN TOTAL, 433 RECTAL CANCER PATIENTS UNDERWENT THE SAME STANDARDIZED PROCEDURE. NON-STOMA (NS) MANAGEMENT WAS USED IN PATIENTS WITH NO SURGICAL DIFFICULTIES AS WELL AS GOOD COLONIC PREPARATION AND QUALITY OF ANASTOMOSES. IN ALL OTHER CASES, DS WAS USED. C-REACTIVE PROTEIN WAS MEASURED DURING POSTOPERATIVE FOLLOW-UP. STAPLING OF THE RECTUM WAS PERFORMED UNDER UPPER TRACTION ABOVE THE LEVATOR ANI DURING LTME USING A CONTOUR CURVED STAPLER (JOHNSON & JOHNSON) AND USING EITHER AN ECHELON FLEX STAPLER (JOHNSON & JOHNSON) DURING RTME. RECONSTRUCTION WAS ALWAYS PERFORMED VIA A STAPLED SIDETO- END COLORECTAL ANASTOMOSIS, USING THE DOUBLE-STAPLING TECHNIQUE (CDH33 PROXIMATE ILS, ETHICON ENDO-SURGERY, JOHNSON & JOHNSON). REPORTED COMPLICATIONS INCLUDED 30 DAY MORTALITY FROM SEPTIC SHOCK (N=1), ANASTOMOTIC LEAKAGE (N=33), PELVIC ABSCESS (N=2), OCCLUSION (N=22), BLEEDING (N=3), CALVIEN- DINDO 2, 3A, 3B AND 4 (N=76). IN CONCLUSION TAILORING DS FOR LCRA SEEMS SAFE AND COULD PROVIDE POTENTIAL BENEFITS IN POSTOPERATIVE MORBIDITY WITH THE SAME LONG-TERM ONCOLOGICAL RESULTS IN NS PATIENTS. PROSPECTIVE, MULTICENTRIC STUDIES SHOULD VALIDATE THIS APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065634 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D