MAUDE Adverse Event Report: THOR PHOTOMEDICINE LTD THOR PHOTOMEDICINE LTD; 810NM 1W CLUSTER (5X200MW) ISSUE 1

Model Number	S1160
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Probe exceeded temperature tests after 10 mins (44.5 c).Thor recommended the replacement of the probe head in order to rectify this, this repair was refused by the customer but other repair / servicing was carried out.Letter sent to customer re.Probe temperatures and advice regarding duty cycle.This mdr is being submitted as a part of a retrospective review and remediation effort based on enhancements made to the company's complaint handling processes.This event is being filed in accordance with a capa which has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.
Event or Problem Description
810nm 1w cluster probe heats up to the point it is uncomfortable to leave it on the skin when treating.

• Brand Name: THOR PHOTOMEDICINE LTD
• Common Device Name: 810NM 1W CLUSTER (5X200MW) 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: 18918774
• Report Number: 3003899624-2024-00003
• Device Sequence Number: 6892748
• Product Code: ILY
• UDI-Device Identifier: 05060494130145
• UDI-Public: (01)05060494130145
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K033923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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: S1160
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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