BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PURSTRING DEVICE

    MDR report key: 12672479 · Received October 21, 2021

    Report

    Report Number
    2647580-2021-03545
    Event Type
    Death
    Date Received
    October 21, 2021
    Date of Event
    May 19, 2021
    Report Date
    October 21, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: MAJOR MODIFICATIONS TO MINIMIZE THORACIC ESOPHAGO-GASTRIC LEAK AND ERADICATE ESOPHAGEAL STRICTURE AFTER IVOR LEWIS ESOPHAGECTOMY SOURCE: J SURG ONCOL. 2021;124:529539. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED 2010 TO 2021, POSTOPERATIVE TO IVOR LEWIS ESOPHAGECTOMY WITH A MODIFIED ESOPHAGOGASTRIC ANASTOMOSIS, ONE PATIENT HAD A LEAK AND DIED OF LONG TERM COMPLICATIONS. LEAK WAS TREATED WITH AN ESOPHAGEAL STENT AND ENDOSCOPIC JEJUNOSTOMY. AFTER A YEAR, THE SAID PATIENT DEVELOPED A BRONCHIAL ESOPHAGEAL FISTULA. THE PATIENT UNDERWENT SURGICAL RECONSTRUCTION AND DIED ON POSTOPERATIVE DAY 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570785 UNKNOWN PURSTRING DEVICE CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY GDJ US SURGICAL PUERTO RICO UNKNOWN PURSTRING DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R