BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YANK FLX REGTIP W/O TROL W/O SUMP TIP

    MDR report key: 855100 · Received May 24, 2007

    Report

    Report Number
    9612030-2007-00031
    Event Type
    Malfunction
    Date Received
    May 24, 2007
    Date of Event
    February 12, 2007
    Report Date
    May 16, 2007
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON MAY 16, 2007, THAT DURING AN OPEN CHOLECYSTECTOMY, THE TIP OF THE YANKAUER SUCTION TUBE WAS NOTED TO BE BROKEN WITH A PIECE MISSING. A SEARCH OF THE OPERATIVE FIELD, PATIENT'S ABDOMEN AND SUCTION TUBE PACKING WAS SEARCHED WITHOUT SUCCESS. THE PATIENT HAS NOT RETURNED. SAMPLE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YANK FLX REGTIP W/O TROL W/O SUMP TIP SUCTION INSTRUMENT JOL TYCO HEALTHCARE/KENDALL 8888501007 633803164

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR