BEUDAMED
    FDA Adverse Event Summary report: N

    NEZHAT-DORSEY TRUMPET VALVE

    MDR report key: 32761 · Received May 8, 1996

    Report

    Report Number
    MW4001174
    Date Received
    May 8, 1996
    Date of Event
    August 17, 1995
    Report Date
    September 14, 1995
    Manufacturer
    AMERICNA HYDRO-SURGICAL
    Product Code
    KQT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DATE OF OCCURRENCE 8/17/95. DURING A SURGICAL LAPAROSCOPY, THE SURGEON WAS USING THE SUCTION IRRIGATOR TO SUCTION SOME BLOOD OUT OF THE ABDOMEN. WHILE USING THIS DEVICE, A PORTION OF THE BOWEL AND FAT ATTACHED TO THE BOWEL WAS SUCKED UP INTO THE DISTAL END OF THE SUCTION TIP. THE SURGEON ATTEMPTED TO RELEASE THE BOWEL BY IRRIGATING THROUGH THE DEVICE AND BY THE COMPLETE RELEASE OF SUCTION, BUT WAS UNSUCCESSFUL. THE SUCTION WAS OPERATING AT THE REGULAR FLOW RATE. A LAPAROTOMY WAS PERFORMED TO CORRECT THE PROBLEM. THE PT'S BOWEL APPEARED BRUISED INITIALLY. FOLLOW-UP CONTACT WITH THE SURGEON REGARDING THE PT REVEALED THAT THE PT WAS DOING WELL. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEZHAT-DORSEY TRUMPET VALVE LAPAROSCOPIC SUCTION/IRRIGATION SYSTEM KQT AMERICNA HYDRO-SURGICAL HD4021

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO