BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 1060929 · Received June 13, 2008

    Report

    Report Number
    2647580-2008-00347
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 2, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE RPTR: AFTER APPLYING THE DEVICE, THE SURGEON HAD DIFFICULTY REMOVING IT FROM THE PT. THE SURGEON THEN FULLY OPENED THE DEVICE, DETACHED IT FROM THE ANVIL, AND REMOVED IT FROM THE PT. IT WAS THEN NOTICED THAT THE DONUTS WERE NOT COMPLETELY CUT, AND BY USING SURGICAL SCISSORS THE REMAINING TISSUE WAS CUT AND THE ANVIL WAS REMOVED. FOR SECURITY, THE SURGEON ALSO SUTURED THE ANASTOMOSIS TO FINISH THE PROCEDURE. SURGERY TIME WAS EXTENDED BY ONE HR AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P5L682

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention