BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 1040583 · Received May 9, 2008

    Report

    Report Number
    1219930-2008-00363
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 16, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: ESOPHAGECTOMY. PATIENT: MALE. ACCORDING TO THE REPORTER: WHEN PASSING DOWN THROUGH THE ESOPHAGUS, THE ORVIL GOT STUCK. WHEN THE DOCTOR APPLIED PRESSURE TO PULL THE DEVICE, THE ANVIL DETACHED FROM THE TUBE. THEY TRIED TO RETRIEVE THE ORVIL WITH THE SCOPE FROM BOTH SIDES (ORALLY AND THROUGH THE DISTAL END OF THE ESOPHAGUS), EXTENDING SURGICAL TIME ABOUT AN HOUR AND A HALF. THERE WAS SOME EDEMA/SWELLING DUE TO THE MANIPULATION BUT NO SEVERE TRAUMA. THE ANASTOMOSIS WAS PERFORMED HIGHER IN THE ESOPHAGUS. THERE WAS NO BLOOD LOSS, AND TISSUE LOSS WAS NO MORE THAN WHAT WAS ANTICIPATED. NO LEAK TEST WAS NEEDED/PERFORMED, AND NO STAPLE REINFORCEMENT MATERIAL WAS USED. THE ANASTOMOSIS WAS DONE WITH THE ANVIL THAT CAME WITH THE STAPLER, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention