MAUDE Adverse Event Report: CANDELA CORPORATION GENTLEMAX PRO

Model Number	9914-00-9035
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was removed from customer site and evaluated by the national institute of technology and evaluation's (nite), and then a failure analysis evaluation was conducted by candela principal engineering technician.It was confirmed that there are no flammable gases inside or produced by the capacitor.The information suggests that the fire started in the capacitor.The principal engineering technician concluded that the most likely cause of this event was a faulty capacitor.Based on all available information, the most probable cause for this event is cause traced to component failure, where an expected or random component failure without any design or manufacturing issue caused or contributed to this event.Review of risk management documents demonstrate that the reported risk is captured and assessed.No further corrective actions required for this complaint at this time.Risk information is then subject to periodic risk reviews and trend tracking, which may require additional actions and/or review.
Event or Problem Description
On june 12th, 2025, candela corporation became aware of a fire reported by a customer in japan.The fire involved candela gentlemax pro device, serial number: (b)(6).There were no injuries to patients, providers, nor clinic staff.A nurse at the customer site called a candela field service engineer to report that there was a "clapping noise" from machine during irradiation.There were no device fault codes, alarms, or error messages displayed.During the call, smoke came out of the machine and the fire alarm in the clinic went off.The clinic owner instructed everyone (patient, doctor, nurses, staff, etc.) to evacuate the building.When the fire department arrived, it was alleged that the "machine caused a fire." the device was removed from the clinic to be evaluated by a third party, and is now enroute to candela headquarters, marlborough, massachusetts, usa for additional testing and failure analysis.The complaint investigation is pending.

• Brand Name: GENTLEMAX PRO
• Common Device Name: GENTLEMAX PRO
• Manufacturer (Section D): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer (Section G): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer Contact: greg wallender ; 251 locke drive; marlborough, MA 01752 ; 5083580463
• MDR Report Key: 22478208
• Report Number: 3016496662-2025-00004
• Device Sequence Number: 12748294
• Product Code: GEX
• UDI-Device Identifier: 00817495020013
• UDI-Public: (01)00817495020013(11)221001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 9914-00-9035
• Device Catalogue Number: 9914-00-9035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2022
• 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