BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA Q REFLEX

    MDR report key: 8480547 · Received April 3, 2019

    Report

    Report Number
    3013515803-2019-00001
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    March 8, 2019
    Report Date
    March 26, 2019
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    UDI-DI
    09342395000427
    PMA / PMN Number
    K021550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS SOON AS ELLEX MEDICAL BECAME AWARE OF THE INCIDENT, ELLEX HAS VERIFIED THE PERFORMANCE OF THE UNIT THROUGH A PRODUCT ACCEPTANCE FAULT (PAF) RECORD. THE UNIT OPERATES TO SPECIFICATIONS AND THE MINOR MISALIGNMENT COULD NOT HAVE CAUSED THE ADVERSE EVENT AS WAS ALSO CONFIRMED BY THE PHYSICIAN. THE PHYSICIAN MENTIONED THE PATIENT STATUS WOULD RESOLVE WITH TIME. FUTURE VISUAL ACUITY CHECKS WILL TAKE PLACE AGAIN IN THE COMING WEEKS. HE FEELS CONFIDENT THAT THE PATIENT'S VA WILL CONTINUE TO IMPROVE. THE COMPLAINT ALSO MENTIONED ABOUT PITTING OF THE IOL BY ANOTHER DOCTOR HOWEVER THE VISUAL ACUITY WAS UNAFFECTED. THE GENERAL DEVICE ASPECTS WITH RESPECT TO USABILITY, INSTRUCTIONS FOR USE AND THE RISK CONTROLS WERE EVALUATED . ADEQUACY OF DEVICE DESIGN : INDICATIONS OF PARAMETERS RELEVANT TO SAFETY: ANTERIOR AND POSTERIOR OFFSET LOCATED ON THE LASER HEAD CONTROL KNOB ARE LETTER AND COLOUR CODED. ACCURACY OF CONTROLS : OFFSET RANGE IS WELL DEFINED WITH THE REQUIRED TOLERANCE. ADEQUACY OF LABELLING: OPERATOR MANUAL INCLUDES SUFFICIENT INSTRUCTIONS , WARNINGS, PRECAUTIONS FOR THE SAFE USE OF THE DEVICE AND THE LABELLING IS CONSIDERED ADEQUATE. RISK MANAGEMENT :THE RISK ASSESSMENT INCLUDE THE RISK CONTROL MEASURES FOR RISK (B)(4). CUSTOMER COMPLAINTS : THE DEVICE HAS BEEN IN USE FOR APPROXIMATELY LESS THAN 2 YEARS FROM THE DATE OF MANUFACTURE, NO OTHER UNTOWARD INCIDENTS RELATED TO DEVICE USE WERE REPORTED APART FROM THIS EVENT. ANY SUBSEQUENT FINDINGS ON PATIENT STATUS WILL BE UPDATED THROUGH A FOLLOW-UP REPORT. E2018008.

    Description of Event or Problem · 0

    DOCTOR INADVERTENTLY HIT A PATIENT'S RETINA IN THE LEFT EYE WITH THE YAG LASER AND IT CREATED A SMALL CONTUSION NOTED BY A WHITE MARK AND THIS CAUSED A MODERATE BLEED INTO THE VITREOUS WHICH REDUCED THE PATIENT'S VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272657 ULTRA Q REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U 09342395000427

    Patients

    Seq Age Sex Outcome Treatment
    1 Other