BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F.F.P.F. EMC

    MDR report key: 6127748 · Received November 25, 2016

    Report

    Report Number
    2428235-2016-00009
    Event Type
    Injury
    Date Received
    November 25, 2016
    Date of Event
    August 4, 2016
    Report Date
    November 23, 2016
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    K972072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATOR INDICATED BLEPHAROPLASTY PROCEDURE WAS PERFORMED WITHOUT THE RECOMMENDED CORNEAL EYE SHIELDS. THE INSTRUCTION MANUAL DIM-45-01, PAGE 3 STATES "ELLMAN STRONGLY RECOMMENDS THE USE OF THE ELLMAN CORNEAL EYE SHIELDS FOR ANY RADIOFREQUENCY SURGICAL PROCEDURE INVOLVING THE EYELID AND THE IMMEDIATE SURROUNDING AREAS. DEVICE WAS UNABLE TO BE EVALUATED AS IT WAS NOT RETURNED FOLLOWING PROCEDURE, AND USER DID NOT COMMUNICATE THE FINAL CONDITION OF PATIENT. TREATMENT AREA WAS CLEANED WITH BETADINE IMMEDIATELY POST TREATMENT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT BLEPHAROPLASTY PROCEDURE USING A RADIOFREQUENCY GENERATOR WITHOUT THE USE OF THE RECOMMENDED CORNEAL EYE SHIELDS, RESULTING IN AN ABRASION OR PUNCTURE TO THE CORNEA. ALSO, THE PATIENT MADE A GROSS MOVEMENT DURING SURGERY CAUSING THE MISPLACEMENT OF CAUTERIZATION, AND HAD DIFFICULTY WITH VISION IMMEDIATELY POST TREATMENT. USER STATED TREATMENT WAS PERFORMED WITH A SURGICAL HANDPIECE FROM A DIFFERENT MANUFACTURER, AND THAT PARAMETERS WERE NOT WITHIN THE RECOMMENDED NORMAL LIMITS OF OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777873 F.F.P.F. EMC SURGITRON F.F.P.F. EMC GENERATOR GEI CYNOSURE, INC. DBA ELLMAN EMC110A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other