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

Model Number S2160

Device Problem Excessive Heating (4030)

Patient Problem Burning Sensation (2146)

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

Faults confirmed.Blue wire shorted to ground in 1.5m cable.Replaced complete cable.No corrective action was required.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 Description

On the last use, the middle section of the 810nm 1w cluster (5x200mw) issue 1 was hot to touch - not the head but the mid section of the lead.

• Type of Device: 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: 18279422
• MDR Text Key: 329941362
• Report Number: 3003899624-2023-00004
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/06/2023

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
• Device Model Number: S2160
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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