BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE CONTROLLER

    MDR report key: 4643460 · Received March 24, 2015

    Report

    Report Number
    MW5041701
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    February 24, 2015
    Report Date
    March 10, 2015
    Manufacturer
    HOLOGIC GYN SURGICAL SOLUTIONS
    Product Code
    HIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING HYSTEROSCOPY THE FLUID DEFICIT WAS NOT CORRECT ON THE PUMP. THE HANDPIECE ALSO JAMMED AND WAS REPLACED. NEW HANDPIECE SHOWED FLUID DEFICIT RAPIDLY RISE. PUMP DEFICIT READ 7800 ML. MANUAL CALCULATION DEFICIT WAS 4000 ML. DEVELOPED PULMONARY EDEMA FROM EXCESS SALINE POST OPERATION HYPOXIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197759 MYOSURE CONTROLLER MYOSURE CONTROLLER HIH HOLOGIC GYN SURGICAL SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention