BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO-SURG PLUS

    MDR report key: 1317630 · Received February 11, 2009

    Report

    Report Number
    1317630
    Event Type
    Malfunction
    Date Received
    February 11, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 11, 2009
    Manufacturer
    DAVOL INC.
    Product Code
    KQT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SUCTION IRRIGATOR WAS LEAKING FROM THE BATTERY PACK. NO HARM TO STAFF OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO-SURG PLUS IRRIGATOR, LAPAROSCOPIC, BATTERY POWERED KQT DAVOL INC. * JUSDF003

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR