BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPUS

    MDR report key: 18196484 · Received November 22, 2023

    Report

    Report Number
    3004167969-2023-00014
    Event Type
    Death
    Date Received
    November 22, 2023
    Date of Event
    November 12, 2023
    Report Date
    October 2, 2024
    Manufacturer
    ALMA LASERS, LTD
    Product Code
    GEI
    UDI-DI
    17290110121782
    PMA / PMN Number
    K201520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 16TH, 2023, ALMA LASERS LTD BECAME AWARE OF A POTENTIAL ADVERSE EVENT, REPORTED BY ALMA LASERS INC., A US IMPORTER, THAT RECEIVED A COMMUNICATION FROM A CUSTOMER THAT REPORTED A PATIENT DEATH FOUR DAYS POST OPUS TREATMENT. ALMA LASERS LTD, THE DEVICE MANUFACTURER, REQUESTED ALMA LASERS INC. TO RETRIEVE THE OPUS TO ALMA'S DEPORT FOR TESTING, BUT THE CUSTOMER WAS UNWILLING TO PROVIDE THE OPUS SYSTEM AND PLASMA HANDPIECE FOR DEVICE INSPECTION. DURING THE EVALUATION, WE LEARNED FROM ALMA CUSTOMER (THE INITIAL REPORTER) THAT THE CAUSE OF DEATH MOST PROBABLY WAS A BLOOD CLOT, AND THAT THE PATIENT DOES HAVE UNDERLYING MEDICAL CONDITIONS, SUCH AS HIGH BLOOD PRESSURE AND HIGH CHOLESTEROL. EVALUATION OF THE PRODUCT MANUFACTURING RECORDS (DHR) REVEALED THAT THE DEVICE FULLY MEETS SPECIFICATION AND IN THE APPROXIMATELY 16 MONTHS OF USE THERE HAVE BEEN NO RECORDED INSTANCES OF MALFUNCTIONS OR OPERATIONAL ISSUES WITH THE DEVICE. OUR EVALUATION CONCLUDED THAT THE DEATH WAS NOT RELATED TO THE TREATMENT. UF/IMPORTER REPORT #:(B)(4). UDI RELATED DATA QUALITY UPDATES ONLY: THIS SUPPLEMENTAL REPORT REPRESENTS A CORRECTION TO A PREVIOUSLY SUBMITTED MDR THE CORRECTION IS PERFORMED FOLLOWING FDA REQUEST, THE UDI NUMBER WAS ADDED.

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 16TH, 2023, ALMA LASERS LTD BECAME AWARE OF A POTENTIAL ADVERSE EVENT, REPORTED BY ALMA LASERS INC., A US IMPORTER, THAT RECEIVED A COMMUNICATION FROM A CUSTOMER THAT REPORTED A PATIENT DEATH FOUR DAYS POST OPUS TREATMENT. ALMA LASERS LTD, THE DEVICE MANUFACTURER, REQUESTED ALMA LASERS INC. TO RETRIEVE THE OPUS TO ALMA'S DEPORT FOR TESTING, BUT THE CUSTOMER WAS UNWILLING TO PROVIDE THE OPUS SYSTEM AND PLASMA HANDPIECE FOR DEVICE INSPECTION. DURING THE EVALUATION, WE LEARNED FROM ALMA CUSTOMER (THE INITIAL REPORTER) THAT THE CAUSE OF DEATH MOST PROBABLY WAS A BLOOD CLOT, AND THAT THE PATIENT DOES HAVE UNDERLYING MEDICAL CONDITIONS, SUCH AS HIGH BLOOD PRESSURE AND HIGH CHOLESTEROL. EVALUATION OF THE PRODUCT MANUFACTURING RECORDS (DHR) REVEALED THAT THE DEVICE FULLY MEETS SPECIFICATION AND IN THE APPROXIMATELY 16 MONTHS OF USE THERE HAVE BEEN NO RECORDED INSTANCES OF MALFUNCTIONS OR OPERATIONAL ISSUES WITH THE DEVICE. OUR EVALUATION CONCLUDED THAT THE DEATH WAS NOT RELATED TO THE TREATMENT. *** UF/IMPORTER REPORT #:3004450661-2023-00017.

    Description of Event or Problem · 0

    ON 16-NOV-23 IT WAS REPORTED TO ALMA LASERS LTD ABOUT PATIENT DEATH THAT WAS LIKELY CAUSED BY A BLOOD CLOT. THE IMPORTER HAD INFORMED THAT THE PATIENT RECEIVED AN OPUS PLASMA TREATMENT 4 DAY PRIOR SHE PASSED AWAY.

    Description of Event or Problem · 0

    ON 16-NOV-2023 IT WAS REPORTED TO ALMA LASERS LTD ABOUT PATIENT DEATH THAT WAS LIKELY CAUSED BY A BLOOD CLOT. THE IMPORTER HAD INFORMED THAT THE PATIENT RECEIVED AN OPUS PLASMA TREATMENT 4 DAY PRIOR SHE PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203907 OPUS OPUS GEI ALMA LASERS, LTD 17290110121782

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death