BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO-FLOR IRRIGATOR WITH NEZHAT-DORSEY

    MDR report key: 35643 · Received August 16, 1996

    Report

    Report Number
    MW1009731
    Event Type
    Malfunction
    Date Received
    August 16, 1996
    Date of Event
    July 30, 1996
    Report Date
    August 6, 1996
    Manufacturer
    DAVOL, INC.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, HANDPIECE LEAKED AND WOULD NOT COAGULATE PROPERLY. ASSUMED THAT O-RINGS WERE BAD. NO INJURY TO PT. UNABLE TO RETURN DEFECTIVE DEVICE TO MFR FOR EVALUATION AS IT HAD TO BE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO-FLOR IRRIGATOR WITH NEZHAT-DORSEY SMOKEVAC TRUMPET VALVE KNS DAVOL, INC. 0025530 21BG4015

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other