BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES ORVIL AUTOMATIC 25MM DEVICE

    MDR report key: 5606392 · Received April 25, 2016

    Report

    Report Number
    1219930-2016-00367
    Event Type
    Injury
    Date Received
    April 25, 2016
    Date of Event
    March 29, 2016
    Report Date
    March 30, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: EEAXL2535, EEA XL 25MM SINGLE USE STAPLER WITH 3.5MM STAPLES, DEVICE WAS ALSO USED, LOT # P5A0705KX; PROCODE GDW. THE 510K K062850.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER: (B)(6). MFR CONTACT: (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A GASTRECTOMY PROCEDURE, THE SURGEON ATTEMPTED TO LOAD THE ANVIL TO THE SPIKE OF THE EEA STAPLER. THE SURGEON STATED HE THOUGHT IT HAD CLICKED. IT CAME OFF, SO THE SURGEON TRIED TO MATE THE ANVIL TO THE SPIKE AGAIN BUT EACH TIME HE DID, THE ANVIL WOULD NOT STAY ON THE SPIKE. WHEN HE APPLIED PRESSURE TO PUSH THE SPIKE INTO THE ANVIL THE WINGNUT AT THE REAR OF THE EEA STAPLER WOULD TURN. AT THIS TIME ANOTHER EEA STAPLER WAS OPENED TO USE WITH THE FIRST ANVIL (THE FIRST EEA STAPLER WAS NEVER FIRED). WHEN THE ANVIL IN THE ESOPHAGUS WAS BEING PULLED DOWN, IN PREPARATION TO MATE IT WITH THE NEW STAPLER THAT HAD BEEN OPENED, THE ANVIL PULLED STRAIGHT THROUGH THE TISSUE. THE SURGEON TRANSECTED 1CM OF ESOPHAGEAL TISSUE. THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE. ANOTHER ORVIL WAS THEN OPENED AND PASSED TRANSORALLY. THE ANVIL WAS MATED TO THE EEA STAPLER AND FIRED. THE PROCEDURE WAS CONVERTED TO OPEN. SURGICAL TIME WAS DELAYED BY MORE THAN 30 MINUTES. PATIENT WAS INTENDED TO GO TO THE FLOOR AND HAD TO GO TO ICU INSTEAD. NOTHING FELL IN THE PATIENT CAVITY. NO REINFORCEMENT MATERIAL WAS USED. LAST KNOWN PATIENT STATUS: STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259173 DST SERIES ORVIL AUTOMATIC 25MM DEVICE IMPLANTABLE STAPLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EEAORVIL25A N5D0589X

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R| S