THOR PHOTOMEDICINE LTD

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THE TRIGGER POINT PROBE HAS BEEN TURNING ON INVOLUNTARILY WHEN THE CONTROL UNIT IS SWITCHED ON. THE LASER WILL START WITHOUT MANUALLY PRESSING THE ON/OFF BUTTON. THEY HAVE TRIED THE TRIGGER POINT PROBE IN TWO CONTROL UNITS THAT THEY OWN AND IT INVOLUNTARILY TURNS ON IN BOTH. THEY DO NOT HAVE THIS PROBLEM WITH ANY OTHER PROBE. THE MALFUNCTION IS EASILY IDENTIFIED AND THERE WAS NO ADVERSE EVENT. THOR CONTACTED THE CUSTOMER AND REQUESTED RETURN OF THE PROBE AS SOON AS POSSIBLE. THE DEVICE WAS RETURNED AND INVESTIGATED AND THE ISSUE IS TRACED TO THE CABLE SHORTING AT THE PLUG. THE PROBE SWITCHES AND THE CONTROL UNIT FAULTS WHEN THE CABLE IS MOVED AT THE PLUG END. THOR HAVE ASSESSED THE ISSUE FOR SAFETY CONCERNS. THIS MDR IS BEING SUBMITTED AS THERE IS A POTENTIAL (RISK ASSESSED AS BEING HIGHLY IMPROBABLE) OF POSSIBLE DAMAGE TO THE EYE IF THE USER OR PATIENT'S EYES ARE EXPOSED TO A LASER BEAM IN CLOSE PHYSICAL PROXIMITY (LESS THAN 0.64 METRES) WITHOUT USING THE PROTECTIVE EYEWARE. THIS IS A KNOWN RISK OF LASER EMITTING DEVICES AND THOR INCLUDES INSTRUCTIONS ON USING THE SUPPLIED SAFETY EYEWEAR WHEN USING LASER PROBES.

Description of Event or Problem

THE TRIGGER POINT PROBE HAS BEEN TURNING ON INVOLUNTARILY WHEN THE CONTROL UNIT IS SWITCHED ON. THE LASER WILL START WITHOUT MANUALLY PRESSING THE ON/OFF BUTTON.