BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS HIGH DEFINITION LCD MONITOR

    MDR report key: 3131469 · Received May 8, 2013

    Report

    Report Number
    8010047-2013-00146
    Event Type
    Other
    Date Received
    May 8, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 10, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    NWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. THE POWER SUPPLY WAS IMPROPERLY AFFIXED TO THE PLATE COVER WITH TWO ZIP TIES AND ATTACHED TO THE BOOM ARM. PER THE USER FACILITY, THE INSTALLATION WAS PERFORMED BY OLYMPUS. THE USER FACILITY INDICATED THAT THE DEVICE WAS STILL IN USE. THE USER FACILITY REPORTED THE INCIDENT TO FDA. OLYMPUS FOLLOWED-UP WITH THE FIELD SERVICE ENGINEER (FSE) TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. THE FSE REPORTED THAT POSSIBLY LOOSE SCREWS ON THE PLATE COVER RESULTED IN THE REPORTED EVENT. NO PRODUCT WAS RETURNED TO OLYMPUS. THE MOST LIKELY CONTRIBUTING FACTOR WAS UNSATISFACTORY INSTALLATION. OLYMPUS WAS INFORMED THAT THE USER FACILITY CORRECTED THE INSTALLATION BY PLACING THE POWER SUPPLY ONTO THE CEILING AND REWIRING THE LOW VOLTAGE POWER SUPPLY FROM THE MONITOR TO PREVENT REOCCURRENCES. ALL OF THE MONITORS WITHIN THE FACILITY WERE REINSTALLED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A VIDEO-ASSISTED THORACOSCOPY SURGERY (VATS) THERAPEUTIC PROCEDURE, THE PLATE COVER WITH THE ATTACHED POWER SUPPLY FELL OFF FROM THE REAR OF THE MONITOR (WHICH WAS ATTACHED TO BOOM ARM) TO THE GROUND, ALMOST HITTING A SCRUB NURSE. NO ONE WAS INJURED. THE PROCEDURE WAS SIGNIFICANTLY PROLONGED. THE PLATE COVER HAD TWO EXPOSED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202413 OLYMPUS HIGH DEFINITION LCD MONITOR MONITOR NWB OLYMPUS MEDICAL SYSTEMS CORPORATION OEV261H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 BOOM WITH UNK MODEL NUMBER, MFG BY TRUMP