BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 14434710 · Received May 19, 2022

    Report

    Report Number
    3005075853-2022-03247
    Event Type
    Death
    Date Received
    May 19, 2022
    Date of Event
    September 24, 2020
    Report Date
    May 18, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 06/14/2022. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: COMPARISON OF GREATER CURVATURE AND LESSER CURVATURE CIRCULAR-STAPLED ESOPHAGOGASTROSTOMY AFTER ESOPHAGECTOMY IN PATIENTS WITH ESOPHAGEAL CANCER: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL. AUTHORS: KEN SASAKI, ITARU OMOTO, YASUTO UCHIKADO, HIROSHI OKUMURA, MASAHIRO NODA, YUSUKE TSURUDA, YOSHIAKI KITA, TAKAAKI ARIGAMI, SHINICHIRO MORI, HIROSHI KURAHARA, AKIHIRO NAKAJYO, CHIHAYA KORIYAMA, SHOJI NATSUGOE, TAKAO OHTSUKA. CITATION CITE: SURGERY TODAY (2021) 51:575¿581 HTTPS://DOI.ORG/10.1007/S00595-020-02147-8. THE PURPOSE OF THIS STUDY IS TO COMPARE THE INTEGRITY OF ESOPHAGOGASTROSTOMY BETWEEN THE ESOPHAGUS AND THE GC OR LC SIDE OF THE GASTRIC CONDUIT.USING A CIRCULAR STAPLER TO CREATE AN ANASTOMOSIS FOR ESOPHAGOGASTROSTOMY AFTER ESOPHAGECTOMY IS WELL ACCEPTED; HOWEVER, IT REMAINS UNCERTAIN IF THE GREATER CURVATURE (GC) OR LESSER CURVATURE (LC) OF THE GASTRIC CONDUIT IS BETTER FOR THE ANASTOMOSIS. THE SUBJECTS OF THIS STUDY WERE 70 PATIENTS WHO UNDERWENT ESOPHAGECTOMY AND WERE RANDOMIZED TO A ¿GC¿ GROUP AND AN ¿LC¿ GROUP (N = 35 EACH). IN THE GC GROUP THE GASTRIC CONDUIT WAS PULLED UP TO THE NECK THROUGH THE POSTERIOR MEDIASTINAL, RETROSTERNAL, OR SUBCUTANEOUS ROUTE, AND AN ESOPHAGOGASTROSTOMY WAS PERFORMED USING A PROXIMATE CURVED INTRALUMINAL STAPLER WITH A 25-MM (ETHICON ENDO- SURGERY, CINCINNATI, OH, USA) END-TO-SIDE ANASTOMOSIS. REPORTED COMPLICATION INCLUDED ANASTOMOTIC LEAKAGE (N=9), SURGICAL SITE INFECTION (N=13), RECURRENT LARYNGEAL NERVE PALSY(N=3), MORTALITY (N=1). IN CONCLUSION AL RATES AND POSTOPERATIVE COMPLICATIONS WERE COMPARABLE AMONG PATIENTS UNDERGOING ESOPHAGOGASTROSTOMY USING A CIRCULAR STAPLER AT THE GC OR LC SIDE. HOWEVER, FACTORS OTHER THAN THOSE RELATED TO THE TECHNIQUE AND PATIENTS¿ CHARACTERISTICS MAY PLAY A MAJOR ROLE BECAUSE THE LEAKAGE SITES WERE SIGNIFICANTLY DIFFERENT IN THE TWO GROUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891448 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D