BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTCEPS

    MDR report key: 1770085 · Received July 15, 2010

    Report

    Report Number
    1770085
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 15, 2010
    Manufacturer
    STARION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE CLEANING DEBRIS OFF THE DISPOSABLE INSTRUMENT (STARION FORCEPS) DURING SURGERY, SCRUB TECH NOTICED LOOSE WIRE FROM TIP OF FORCEPS. FORCEPS NOT USED AFTER DEFECT NOTED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================LOOSE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTCEPS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STARION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR