BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 2870127 · Received December 4, 2012

    Report

    Report Number
    1219930-2012-00962
    Event Type
    Injury
    Date Received
    December 4, 2012
    Report Date
    November 20, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY US SUSRGICAL
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: OESOPHAGECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE SURGEON DIDN'T MANAGE TO CONNECT THE ANVIL TO THE INSTRUMENT. THE ANVIL DISCONNECTED EACH TIME THE SURGEON TRIED TO TIGHTEN THE INSTRUMENT. AFTER SEVERAL TRIES, THE SURGEON FINALLY CONVERTED INTO AN OPEN PROCEDURE AND PERFORMED MANUAL SUTURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN LP, FORMERLY US SUSRGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other