BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 12233209 · Received July 27, 2021

    Report

    Report Number
    3005075853-2021-04175
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    February 20, 2020
    Report Date
    July 1, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE SEE ATTACHED JOURNAL ARTICLE. BATCH # UNK. (B)(4). 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. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A STUDY INVESTIGATING THE PERFUSION OF COLORECTAL ANASTOMOSES USING FLUORESCENCE ANGIOGRAPHY: RESULTS OF THE FLAG RANDOMIZED TRIAL. AUTHORS: M. ALEKSEEV, E. RYBAKOV, Y. SHELYGIN, S. CHERNYSHOV AND I. ZARODNYUK. CITATION CITE: 2020 THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. 22, 1147¿1153 DOI:10.1111/CODI.15037. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF INDOCYANINE GREEN (ICG) FLUORESCENCE ANGIOGRAPHY (FA) IN REDUCING THE INCIDENCE OF ANASTOMOTIC LEAKAGE (AL) FOLLOWING COLORECTAL ANASTOMOSIS. A SINGLE-CENTRE RANDOMIZED TRIAL WAS UNDERTAKEN BETWEEN 2018 AND 2019. THOSE PATIENTS WHO UNDERWENT A STAPLED COLORECTAL ANASTOMOSIS WERE RANDOMIZED 1:1 FOR ICG FA VERSUS VISUAL CLINICAL ASSESSMENT OF BLOOD PERFUSION OF THE ANASTOMOSED COLON AND RECTAL STUMP (NON-ICG FA GROUP). THE PRIMARY ENDPOINT WAS TO ASSESS WHETHER ICG FA WAS ASSOCIATED WITH A REDUCTION IN THE INCIDENCE OF AL. SECONDARY OUTCOMES WERE THE RATE OF POSTOPERATIVE COMPLICATIONS AND CHANGE IN THE LEVEL OF BOWEL RESECTION. A TOTAL OF 380 PATIENTS UNDERGOING SIGMOID AND RECTAL RESECTION WERE ENROLLED. AFTER RANDOMIZATION, THREE PATIENTS WERE EXCLUDED. THE RESULTS OF 377 CASES WERE AVAILABLE FOR ANALYSIS; 187 HAD ICG FA AND 190 WERE IN THE NON-ICG FA GROUP. IN ALL CASES, AN END-TO-END STRAIGHT COLORECTAL ANASTOMOSIS WAS FASHIONED USING A DOUBLE STAPLING TECHNIQUE. THE RECTUM WAS TRANSECTED USING A LINEAR STAPLER (CONTOUR CURVED CUTTER STAPLER, ETHICON, CINCINNATI, OHIO, USA, US0041) OR BY AN ECHELON FLEX ENDOPATH 60 MM STAPLER (ETHICON). COLORECTAL ANASTOMOSIS WAS CREATED BY A CIRCULAR STAPLER WITH DST SERIES TECHNOLOGY EEA AUTOSUTURE 31 MM. AN AIR LEAK TEST WAS USED IN ALL PATIENTS. REINFORCEMENT OF THE ANASTOMOSIS WAS LEFT TO THE DISCRETION OF THE SURGEON. INTRAOPERATIVE COMPLICATIONS AND ADVERSE EVENTS WERE RECORDED. REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N=4), PARALYTIC ILEUS (N=6), ABDOMINAL BLEEDING (N=1), MECHANICAL ILEUS (N=1), CALVIEN-DINDO GRADE I (N=9), CALVIEN-DINDO GRADE II (N=6), CALVIEN-DINDO GRADE IIIA (N=1), CALVIEN-DINDO GRADE IIIB (N=7), IMPAIRED BLOOD SUPPLY (N=36) AND ANASTOMOSIS LEAK (N=48) PATIENTS UNDERWENT REOPERATION FOR GRADE C ANASTOMOSIS LEAK. IN CONCLUSION ICG FA IS WELL TOLERATED AND SIMPLE TO PERFORM. ITS APPLICATION RESULTED IN A CHANGE OF THE RESECTION MARGIN IN 20% OF PATIENTS. SIGNIFICANT REDUCTIONS IN AL WERE OBSERVED IN PATIENTS UNDERGOING LOW ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132640 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention