BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED LAPAROSCOPIC CARE KIT

    MDR report key: 3121793 · Received May 14, 2013

    Report

    Report Number
    MW5030205
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 14, 2013
    Manufacturer
    NEW WAVE SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    D-HELP (HEATED DEFOGGER) WAS OPENED ON CASE. WOULD NOT TURN ON OR HEAT UP. SECOND ONE WAS OPENED. ALSO WOULD NOT TURN ON OR HEAT UP. THIRD ONE OPENED AND IT WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212227 ADVANCED LAPAROSCOPIC CARE KIT NEW WAVE SURGICAL D-HELP KIT GCJ NEW WAVE SURGICAL CORP. 21-345 B2113H

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR