BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW

    MDR report key: 3146884 · Received May 6, 2013

    Report

    Report Number
    3146884
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HIGH FLOW INSUFFLATION TUBING HAD A HOLE IN IT NEAR WHERE THE TUBING SCREWS ONTO THE TROCAR; SLIGHT DELAY IN CASE RELATED TO OPENING NEW TUBING. NO PATIENT HARM. THE HOLE WAS DISCOVERED WHILE IN USE. BECAUSE OF THIS EVENT, THE CASE WAS DELAYED WHILE ANOTHER TUBING WAS OBTAINED. IT TOOK A SHORT TIME TO LOCATE THE HOLE. THE HOLE IN THE TUBING WAS NOT VISIBLE WHEN THE PACKAGE OPENED. THE PACKAGE WAS INTACT.======================MANUFACTURER RESPONSE FOR HIGH FLOW INSUFFLATION TUBING, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================UNKNOWN AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ROBOT ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHERECTOMY WITH CYSTOCSOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198143 HIGH FLOW INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE FCX STRYKER ENDOSCOPY * 13043FE2

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR DAVINCI SURGICAL SYSTEM