BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 2061220 · Received April 5, 2011

    Report

    Report Number
    1219930-2011-00269
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC GASTRIC BYPASS. ACCORDING TO THE REPORTER: DR. (B)(6) AND DR. (B)(6) USED THE ORVIL DEVICE ON A LAPAROSCOPIC GASTRIC BYPASS. THE ANESTHESIOLOGIST PASSED THE ORVIL DOWN AND WHEN THE OG TUBE POPPED THROUGH THE STOMACH, THE ANVIL WAS NO LONGER ATTACHED. THEY DID AN ENDOSCOPY LOOKING DOWN THE ESOPHAGUS AND INTO THE STOMACH AND ALSO SEARCHED THE MOUTH AND COULD NOT FIND IT. THEY BROUGHT IN AN ENT SURGEON AND REALIZED THE ANVIL HAD RETRACTED BACK UP AND BEHIND THE SOFT PALATE OF THE PATIENT. THE PATIENT EXPERIENCED EXCESSIVE SWELLING AND EDEMA. THE ENT ADVISED THEY KEEP THE PATIENT INTUBATED FOR 48 HOURS. THIS ADDED AN ADDITIONAL HOUR AND FIFTEEN MINUTES TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES EEA ORVIL 25MM DEVICE DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N1A0958UL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention