BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS LYONS DISSECTING FORCEPS W/ATTACHED CORD

    MDR report key: 1161164 · Received September 10, 2008

    Report

    Report Number
    1161164
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 10, 2008
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN PERFORMING A LAPAROSCOPICALLY-ASSISTED SUPRACERVICAL HYSTERECTOMY (LASH), THE BLADE OF THE PK LYONS CAUTERY BROKE OFF INSIDE PATIENT. BLADE WAS LOCATED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS LYONS DISSECTING FORCEPS W/ATTACHED CORD FORCEPS, ESU, DISSECTING GEI GYRUS MEDICAL, INC. * 8171035

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR