BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI 1-FC

    MDR report key: 3674022 · Received January 15, 2014

    Report

    Report Number
    9615010-2014-00003
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    December 16, 2013
    Report Date
    January 15, 2014
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE REPORTED THE FOLLOWING VIA USER FACILITY REPORT(B)(4): "MICROSCOPE CHECKED BEFORE START OF CASE BY STAFF (LIGHT WORKING)"; "LIGHT WORKED THEN SHUT OFF, COULD NOT RE-ILLUMINATE"; "SURGEON PERFORMED MYRINGOTOMY WITH NO TUBE INSERTION"; "DEVICE CHECKED BY CLINICAL ENGINEERING"; "COULD NOT DUPLICATE"; "DEVICE WAS IN FULL WORKING ORDER"; "RETURNED DEVICE TO OR"; "DR AND STAFF REPORTED DEVICE WORKING PROPERLY". THIS INFO IS CONSISTENT WITH THAT REPORTED TO THE MFR'S REP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE START OF A MYRINGOTOMY PROCEDURE, THE OPMI 1-FC MICROSCOPE LIGHT WAS WORKING AND THEN WENT OUT. THE MICROSCOPE WAS REMOVED FROM THE OPERATING ROOM AND THE DOCTOR COMPLETED THE MYRINGOTOMY WITHOUT THE PLANNED TYMPANOSTOMY TUBE INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37952 OPMI 1-FC MICROSCOPE, SURGICAL, GENERAL & PLASTIC EPT CARL ZEISS MEDITEC AG OPMI 1-FC NA

    Patients

    Seq Age Sex Outcome Treatment
    1