BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    MDR report key: 19014065 · Received April 1, 2024

    Report

    Report Number
    3011050570-2024-00122
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 30, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925044111
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, THE CUSTOMER HAVE NOT RETURNED THE DEVICE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO PROVIDE A CORRECTION TO THE INITIAL MEDWATCH REPORT (MDR). FURTHER REVIEW FOUND THERE WAS NO REPORTABLE MALFUNCTION RELATED TO THE SUBJECT DEVICE CAPTURED IN THIS COMPLAINT. THE INITIAL MDR WAS INADVERTENTLY SUBMITTED AS A REPORTABLE MALFUNCTION. THE INITIAL MEDWATCH REPORTED THAT THE PREMIUM SUPERPULSED LASER SYSTEM EXHIBITED A FAILURE MODE/ THE BLAST SHIELD DOES NOT FIT PROPERLY; HOWEVER; PER THE LEGAL MANUFACTURE, THIS ISSUE OF IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE PREMIUM SUPERPULSED LASER SYSTEM EXHIBITED A FAILURE MODE/ THE BLAST SHIELD DOES NOT FIT PROPERLY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361304 SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC. TFL-PLS 00821925044111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown