BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA INSTR. W/TILT-TOP

    MDR report key: 919260 · Received September 21, 2007

    Report

    Report Number
    2647580-2007-00460
    Event Type
    Injury
    Date Received
    September 21, 2007
    Date of Event
    August 15, 2007
    Report Date
    August 23, 2007
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USS REFERENCE #: 200708-1919.

    Description of Event or Problem · 1

    PROCEDURE TYPE: ROUX-EN-Y. PATIENT GENDER: UNKNOWN. ACCORDING TO THE REPORTER: THE SURGEON SQUEEZED THE WING NUT, BUT COULDN'T CONNECT INSTRUMENT AND ANVIL. ALLEGEDLY HE REMOVED IT BY CUTTING PATIENT SIDE AND USED A NEW INSTRUMENT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO FURTHER DETAILS HAVE BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GAG PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention