BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 867266 · Received May 29, 2007

    Report

    Report Number
    867266
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Date of Event
    May 11, 2007
    Report Date
    May 29, 2007
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCISSORS TIP FELL OFF LAPAROSCOPIC HANDLE WHILE IN PATIENT'S ABDOMEN FOR TUBAL LIGATION. SURGEON WAS UNABLE TO RETRIEVE EQUIPMENT VIA THE LAPAROSCOPIC PORT. PATIENT NEEDED TO UNDERGO LAPAROTOMY TO RETRIEVE THE SCISSOR TIP, EXTENDING THE INCISION, AND INCREASING THE LENGTH OF STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SCISSORS, SURGICAL LRW CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR NO OTHER THERAPIES