MAUDE Adverse Event Report: THOR PHOTOMEDICINE LTD; 660 NM 75 MW DENTAL PROBE

Model Number	S2173
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
No adverse event or user harm reported.This mdr is being submitted as a verbal report on 16 sept 2024 noted the "light guide broke off into the hand of a nurse who was trying to un-jam it"; no user harm occurred, the user did not mention any concern of possible harm at any point.This verbal report relates to an earlier repair request on june 23 2024 stating "the users got rough with handpiece while removing the black plastic tip.The tip lenses were broken and now a new tip will not insert in the handpiece.They must have bent the internal area that the tip fits into".
Additional Manufacturer Narrative
There were no reports of patient or user harm.The initial user report did not note any concerns, injury or user harm.This mdr is being submitted as a later verbal report noted the "light guide broke off into the hand of a nurse who was trying to un-jam it"; no user harm occurred, the user did not mention any concern of possible harm at any point.Thor understands that the submission of this mdr report is delayed beyond the 30 day period.The third party company that was authorised to submit the mdr reports on behalf of thor became unavailable and are no longer used.Setting up thor profile on the esg portal was a protracted process.

• Common Device Name: 660 NM 75 MW DENTAL PROBE
• 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, buckingshire HP7 9-FB ; UK HP7 9FB
• MDR Report Key: 20794891
• Report Number: 3003899624-2024-00006
• Device Sequence Number: 17875797
• Product Code: ILY
• UDI-Device Identifier: 05060494130114
• UDI-Public: (01)05060494130114(11)230421
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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: S2173
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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