BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM - POWERED LASER SURGICAL INSTRUMENT

    MDR report key: 25071765 · Received May 4, 2026

    Report

    Report Number
    MW5187610
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 1, 2026
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    501
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE USER INSTALLED A REPLACEMENT UNIT ONTO THE SPECTRUM DEVICE, 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 MEDICAL DIRECTOR (OWNER) ADVISED THE INDIVIDUAL TO SEEK MEDICAL EVALUATION. THE INDIVIDUAL PRESENTED TO THE EMERGENCY ROOM, WHERE AN EKG WAS PERFORMED WITH NORMAL RESULTS AND NO ADDITIONAL ABNORMALITIES IDENTIFIED. THE USER REPORTED THAT THE SHOCK DID NOT RESULT IN ANY VISIBLE SKIN DAMAGE AND THERE WAS NO BURN PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28932 SPECTRUM - POWERED LASER SURGICAL INSTRUMENT POWERED LASER SURGICAL INSTRUMENT GEX ROHRER AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown