LIGHTFORCE

Description of Event or Problem

CUSTOMER REPORTED LASER HANDPIECE RANDOMLY BECOMES EXTREMELY HOT. THIS HAS RESULTED IN TWO EMPLOYEES SUSTAINING BLISTERS. COMPLAINTS OF MINOR BLISTER FORMATION ON THERAPISTS PALM SIDE OF THUMB. BEGAN IN JANUARY AND HAS PROGRESSIVELY BECOME MORE FREQUENT - RANDOMLY OCCURRING SEVERAL TIMES PER DAY. OSR ALSO REPORTS LG BALL IS SIGNIFICANTLY SCRATCHED. UNKNOWN EXACTLY WHEN INJURIES OCCURRED AND NO PHOTOS OR CONFIRMATION OF FIRST AID APPLIED OBTAINED.

Additional Manufacturer Narrative

CUSTOMER REPORTED LASER HANDPIECE RANDOMLY BECOMES EXTREMELY HOT. THIS HAS RESULTED IN TWO EMPLOYEES SUSTAINING BLISTERS. COMPLAINTS OF MINOR BLISTER FORMATION ON THERAPISTS PALM SIDE OF THUMB. BEGAN IN JANUARY AND HAS PROGRESSIVELY BECOME MORE FREQUENT - RANDOMLY OCCURRING SEVERAL TIMES PER DAY. OSR ALSO REPORTS LG BALL IS SIGNIFICANTLY SCRATCHED. UNKNOWN EXACTLY WHEN INJURIES OCCURRED AND NO PHOTOS OR CONFIRMATION OF FIRST AID APPLIED OBTAINED. RECEIVED HANDPIECE ONLY SO FAR AND AFTER INSPECTING, THE FIBER TIP LOOKED GOOD, WENT TO TEST AND THERE SEEMS TO BE AN INTERNAL FIBER BREAK IN THE CORD ITSELF AS THERE ARE VOIDS (DARK SPOTS) IN THE AIMING BEAM. THE LIGHTFORCE XLI (40W) THERAPY LASER SYSTEM HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF NEW INFORMATION BECOMES AVAILABLE.