BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 9502660 · Received December 20, 2019

    Report

    Report Number
    3005075853-2019-24625
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    January 1, 2013
    Report Date
    November 28, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 04/21/2020. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE(S) CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? UNK.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2013. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: COMBINED LAPAROSCOPIC-THORACOSCOPIC ESOPHAGECTOMY AND INTRATHORACIC ESOPHAGOGASTRIC ANASTOMSIS. AUTHORS: MEIQING XU, CHANGQING LIU, MINGFA GUO, XIANGXIANG SUN, XIAOHUI SUN, JING LUO, JIEYONG TIAN, XIANLIANG JIANG. CITATION: J THORAC DIS 2013;5(6):895-897. DOI: 10.3978/J.ISSN.2072-1439.2013.12.11. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EXPLORE A METHOD OF COMBINED LAPAROSCOPIC-THORACOSCOPIC ESOPHAGECTOMY AND INTRATHORACIC ESOPHAGOGASTRIC ANASTOMOSIS TO REDUCE COMPLICATIONS. FROM OCTOBER 2011 TO JUNE 2013, 112 PATIENTS (78 MALE AND 34 FEMALE; MEAN AGE: 62±8 YEARS; AGE RANGE: 26 TO 78 YEARS) UNDERWENT COMBINED LAPAROSCOPIC-THORACOSCOPIC ESOPHAGECTOMY AND INTRATHORACIC ESOPHAGOGASTRIC ANASTOMOSIS. DURING THE PROCEDURE, THE THORACIC ESOPHAGUS AND MEDIASTINAL LYMPH NODES WERE DISSECTED WITH THE HARMONIC SYNERGY (ETHICON). THE CHEST ANASTOMOSIS WAS STAPLED WITH THE CIRCULAR STAPLER CDH25 (ETHICON) AND PLACED IN THE APEX OF THE RIGHT CHEST. REPORTED COMPLICATION INCLUDED MAJOR ANASTOMOTIC LEAKAGE (N-4) WHICH WERE CURED WITH NO SURGERY, CHYLOTHORAX (N-4) IN WHICH 2 PATIENTS REQUIRED SURGERY, AND ANASTOMOTIC BLEEDING (N-2)WHICH NEEDED URGENT SURGERY. IN CONCLUSION, COMBINED LAPAROSCOPIC-THORACOSCOPIC ESOPHAGECTOMY AND INTRATHORACIC ESOPHAGOGASTRIC ANASTOMOSIS IS TECHNICALLY FEASIBLE AND SAFE, WITH MINIMIZED TRAUMA, LESS OPERATIVE BLOOD LOSS AND QUICK RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301421 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention