BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 25006453 · Received April 27, 2026

    Report

    Report Number
    3031944951-2026-00004
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEX
    UDI-DI
    00860564000317
    PMA / PMN Number
    K123777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS REPLACED AT USER FACILITY. FULL SET OF TESTING WAS DONE AFTER AFFECTED DEVICE WAS RETURNED TO MANUFACTURING FACILITY AND THE PROBLEM COULD NOT BE DUPLICATED. THE SYSTEM PASSED ALL TESTS. AN ARO FORM FDA 2649 WAS SUBMITTED ON 4/27/26.

    Description of Event or Problem · 0

    USER RECEIVED AN ELECTRICAL SHOCK FROM THE HANDPIECE OF THE SPECTRUM DEVICE AFTER INSTALLING A REPLACEMENT PART. THE USER INSTALLED A REPLACEMENT PART ONTO THE UNIT, MADE CONTACT WITH THE COOLING PLATE ON THE HANDPIECE TO ASSESS WHETHER COOLING WAS FUNCTIONING PROPERLY. UPON CONTACT, THE USER REPORTED EXPERIENCING AN ELECTRICAL SHOCK IN THE HAND, WITH SENSATION TRAVELING UP THE ARM AND INTO THE CHEST. IMMEDIATELY AFTER THE INCIDENT, THE USER REPORTED FEELING LIGHTHEADED AND DIZZY. THE USER PRESENTED TO THE EMERGENCY ROOM, WHERE AN EKG WAS PERFORMED WITH NORMAL RESULTS AND NO ADDITIONAL ABNORMALITIES IDENTIFIED. THE USER REPORTED THAT THE SHCOK DID NOT RESULT IN ANY VISIBLE SKIN DAMAGE AND THERE WAS NO BURN MARKS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575799 SPECTRUM POWERED LASER SURGICAL INSTRUMENT GEX ROHRER AESTHETICS, INC. SPECTRUM 00860564000317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown