BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP

    MDR report key: 537187 · Received July 27, 2004

    Report

    Report Number
    2647580-2004-00191
    Event Type
    Injury
    Date Received
    July 27, 2004
    Date of Event
    March 31, 2004
    Report Date
    April 6, 2004
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE INSTRUMENT WAS FIRED BUT THE TISSUE COULD NOT BE CUT COMPLETELY. WHEN THE INSTRUMENT WAS REMOVED FROM THE CAVITY, THE ANASTOMOSIS BROKE. IT WAS ALSO REPORTED THAT THE ANVIL DID NOT TILT. A NEW INSTRUMENT WAS APPLIED AND FIRED. THEN THAT DEVICE COULD NOT BE REMOVED FROM THE CAVITY, AND THE TISSUE WAS NOT STAPLED COMPLETELY. THE ANVIL WAS DISCARDED. SEE ALSO USS REFERENCE #200404-0357 WHICH WAS REPORTED UNDER ASR EXEMPTION #E2001015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GAG PONCE - USS NA P3J816

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention 111985 LOT# P3K830.