BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO SURG IRRIGATOR

    MDR report key: 512101 · Received February 19, 2004

    Report

    Report Number
    512101
    Event Type
    Malfunction
    Date Received
    February 19, 2004
    Date of Event
    November 1, 2003
    Report Date
    November 1, 2003
    Manufacturer
    DAVOL, INC, A DIV OF C.R. BARD INC.
    Product Code
    KQT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HYDROSURG WAS ON BUT WOULD NOT RUN. PISTOL HAND CONTROL WOULD NOT ALLOW FLUIDS TO FLOW. NO FURTHER DETAILS ON THE INCIDENT ARE AVAILABLE AND THE PT OUTCOME IS UNKNOWN. DEVICE USAGE PROBLEM: NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO SURG IRRIGATOR HYDRO SURG LAPAROSCOPIC IRRIGATOR KQT DAVOL, INC, A DIV OF C.R. BARD INC. * T4XF6J
    2 ENDOPATH PROBE PLUS II PISTOL HAND CONTROL EYN ETHICON ENDO-SURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *