MAUDE Adverse Event Report: THOR PHOTOMEDICINE LTD; LX2 CONTROL UNIT

Model Number S1020

Device Problem Excessive Heating (4030)

Patient Problem Burning Sensation (2146)

Event Date 11/23/2023

Event Type  malfunction  

Manufacturer Narrative

The equipment is 15+ years old and thor hasve no record that a service has been carried out for this lx2 control unit (sn (b)(6)).

Event Description

When using the first plug in of s1020 lx2 c control unit, sn (b)(6), with any of these three probes: s1140 104 led cluster probe 660nm & 850nm 2w, s1160 810nm 1w cluster (5x200mw) - issue 1, or s1092 810nm 200mw standard tip after a few uses the machine stops working.Once it cools down, it resumes working.This takes maybe 10 minutes.When using the second plug in with any of these probes, within 10 minutes of use the probe gets very hot to the touch, and can't be used because it would probably burn the skin.

• Type of Device: LX2 CONTROL UNIT
• 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: 18279484
• MDR Text Key: 330816655
• Report Number: 3003899624-2023-00001
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S1020
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1