BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 8218495 · Received January 4, 2019

    Report

    Report Number
    3005075853-2019-15505
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    January 1, 2017
    Report Date
    December 13, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ARTICLE ENTITLED: CIRCULAR STAPLING VERSUS TRIANGULATING STAPLING FOR THE CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS AFTER ESOPHAGECTOMY IN PATIENTS WITH THORACIC ESOPHAGEAL CANCER: A PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL AUTHOR: KEIJI HAYATA, MD, PHD, MIKIHITO NAKAMORI, MD, PHD, MASAKI NAKAMURA, MD, PHD, TOSHIYASU OJIMA, MD, PHD, MAKOTO IWAHASHI, MD, PHD, MASAHIRO KATSUDA, MD, PHD, TOSHIAKI TSUJI, MD, PHD, TOMOYA KATO, MD, JYUNYA KITADANI, MD, AKIHIRO TAKEUCHI, MD, HIROTAKA TABATA, MD, AND HIROKI YAMAUE, MD, PHD.. CITATION: SURGERY. 2017; 162: 131-8. DOI: HTTP://DX.DOI.ORG/10.1016/J.SURG.2017.01.013. THE AUTHORS COMPARED TRIANGULATING STAPLING AND CIRCULAR STAPLING FOR CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS REGARDING THE DECREASE IN ANASTOMOTIC STRICTURE AFTER ESOPHAGECTOMY FOR THORACIC ESOPHAGEAL CANCER. BETWEEN AUGUST 2010 AND APRIL 2014, A TOTAL OF 100 PATIENTS ENROLLED IN THIS RANDOMIZED, CONTROLLED TRIAL AT (B)(6) HOSPITAL AND WERE ALLOCATED RANDOMLY TO EITHER THE CIRCULAR STAPLING GROUP (CS; N-49; 40 MALE AND 9 FEMALE PATIENTS¿ AGE: 68 ± 8; BMI: 22.7 ± 7.9) OR THE TRIANGULATING STAPLING GROUP (TS; N-51; 37 MALE AND 14 FEMALE PATIENTS; AGE: 65 ± 9; BMI: 21.4 ± 2.7). THE CS METHOD WAS AN END-TO-SIDE ANASTOMOSIS USING AN ILS-CDH25 CS STAPLING DEVICE (ETHICON). THE CIRCULAR STAPLER WAS INSERTED INTO THE TIP OF THE GASTRIC CONDUIT, AND THE ANASTOMOSIS WAS CREATED AT THE POSTERIOR WALL OF THE GASTRIC CONDUIT APPROXIMATELY 5 CM FROM THE DISTAL END OF THE GASTRIC CONDUIT. THE TS METHOD WAS AN END-TO-END ANASTOMOSIS USING A LINEAR STAPLING DEVICE, A PARALLEL CLOSING SYSTEM AND AN EZ45-3.5 CUTTING KNIFE (ETHICON). IN THE CS GROUP, REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC STRICTURE (N-8), ANASTOMOTIC LEAKAGE (N-5), REFLUX ESOPHAGITIS (N-6), CHYLOTHORAX (N-1), AND CERVICAL LYMPHATIC LEAKAGE (N-1). IN THE TS GROUP, REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC STRICTURE (N-9), ANASTOMOTIC LEAKAGE (N-1), REFLUX ESOPHAGITIS (N-6), CERVICAL LYMPHATIC LEAKAGE (N-2), INTRATHORACIC BLEEDING (N-1) WHICH REQUIRED REOPERATION, HERNIATION OF THE TRANSVERSE COLON INTO THE CHEST VIA THE ESOPHAGEAL HIATUS (N-1) WHICH REQUIRED REOPERATION, AND DISTURBANCES IN THE PASSAGE OF INGESTED FOODS IN THE GASTRIC CONDUIT AT THE ESOPHAGEAL HIATUS (N-1) WHICH REQUIRED REOPERATION. IN CONCLUSION, THIS STUDY COULD NOT SHOW THAT THE TS METHOD WAS SUPERIOR TO THE CS METHOD FOR CERVICAL ESOPHAGOGASTROSTOMY TO REDUCE ANASTOMOTIC STRICTURE. THE TS METHOD, HOWEVER, MIGHT HAVE THE POTENTIAL TO DECREASE THE RATE OF ANASTOMOTIC LEAKAGE; A LARGE-SCALE RCT WILL BE REQUIRED TO ASSESS THIS QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13087 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention