MAUDE Adverse Event Report: THOR PHOTOMEDICINE LTD THOR PHOTOMEDICINE LTD; 810NM 200MW STANDARD TIP ISSUE 1

Model Number	S2092
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.

• Brand Name: THOR PHOTOMEDICINE LTD
• Common Device Name: 810NM 200MW STANDARD TIP ISSUE 1
• Manufacturer (Section D): THOR PHOTOMEDICINE LTD; units 1 & 2 anglo office park; white lion road; amersham, buckinghamshire HP7 9 FB; UK HP7 9FB
• Manufacturer (Section G): THOR PHOTOMEDICINE LTD; units 1 & 2 anglo office park; white lion road; amersham, buckinghamshire HP7 9 FB; UK HP7 9FB
• Manufacturer Contact: ian clinch ; units 1 & 2 anglo office park; white lion road; amersham, buckinghamshire HP7 9-FB ; UK HP7 9FB
• MDR Report Key: 21653049
• Report Number: 3003899624-2025-00003
• Device Sequence Number: 9276597
• Product Code: ILY
• UDI-Device Identifier: 05060494130220
• UDI-Public: (01)05060494130220(11)180405
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S2092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown