MAUDE Adverse Event Report: CANDELA CORPORATION VBEAM PRIMA LASER SYSTEM

Model Number	VBEAM PRIMA
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190); Noise, Audible (3273)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is pending.Device has been removed from end-user facility and shipped to candela.Candela received device; evaluation pending.
Event or Problem Description
Candela customer, a distributor in netherlands, reported that there was an "explosion" within a vbeam prima which occurred during preventive maintenance of the device.It was reported that there were no injuries related to the event; pcb board was bowed, and no fragments breached the system.Candela team met with customer to further discuss the reported event on 10oct2024.At this time, it was reported that the field service engineer (fse) servicing the device at the time of the malfunction had ringing in his ears (tinnitus) following the event.He had not sought medical attention.Per candela regulatory reportability decision for loud noise occurrence, the laser operates between 50 dba and 70 dba during normal use.If a failure would occur, it would be an impulse acoustical noise above 80dba, but below 140 dba.The user or patient could potentially be subjected to the following condition(s): temporary ringing or buzzing in ear, most conditions lasting less than 16 to 48 hours.Further follow up from customer on (b)(6) 2024 reported that the fse continued to have tinnitus and has sought medical attention.The fse follow-up notes that he started the annual preventive maintenance of the vbeam prima (b)(6) 2024 at (b)(6) hospital.While servicing the vbeam prima and measuring the energy, with all housings mounted, the igbt of the prima malfunctioned.This happened suddenly, without any cause/indication.After the incident, the system's computer was still working.The fse had been working with the system for 2.5 hours before the malfunction occurred.The system was on the right-hand side of the fse, the front of the system, where the igbt of the system is mounted, was on the right-hand side, about 30 cm away from fse.All the covers and shields were on the system.The components of the igbt and the pcb left a dent in the aluminum shields.Since the incident, the fse notes he has had a "noise/squeaking" in his ears and not getting any better.He is "particularly bothered by it at night, when it buzzes in my ears all night where it used to be quiet." the fse indicates he can hear it during the day.However, "it is less noticeable because of the everyday sounds." he has had appointments with both family doctor and an ear, nose, and throat specialist.The fse alleges that results of hearing test show a "slight hearing loss in my right ear compared to my left ear." it is unclear whether the "noise/beeping" is permanent.Additional information was solicitated; unable to obtain a doctor report.
Additional Manufacturer Narrative
Distributor field service engineer (fse) reported, while servicing the vbeam prima and measuring the energy with all housings mounted (system enclosed), the igbt of the prima exploded.Igbt component is located within the system enclosure.This happened suddenly, without any cause/indication, after the explosion the system's computer was still working.All the covers and shields were on the system.The components of the igbt and the pcb left a dent in the aluminum shields; debris did not escape the device.Device was removed from end-user facility by distributor.Distributor shipped device to candela operations in madrid, spain where it was evaluated by candela.Per initial visual inspection of the system, the side cover and internal hv cover were found distorted.Removing both covers showed parts of the hv igbt broken and missing from the assembly.There did not appear to be any other damage surrounding the igbt apart from the bent covers.The remaining hv assembly was checked for damage or loose components and wiring, but nothing was found.Dye kit was from 2023 and 1.4 upgrade had not been completed.After removal of the damaged component and ensuring the system was safe, it was switched on and the device data saved for analysis.Per review of the data, the fault log showed no other issue (except low dye energy) for when the igbt failure occurred.There were no other indications of damaged components or bad connections.The defective igbt was replaced with a new igbt from stock.The system was then tested and the new igbt monitored for signs of failure; could not reproduce any fault in the system and testing was completed.Testing with a replaced igbt was successful.It therefore indicates that component failure of the of the igbt module occurred without external factors.The most probable cause for this event can be traced to cause traced to component failure indicating that this is a random or expected component failure without any design or manufacturing issue.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.The igbt component was replaced and tested.It was determined that the system can be put back into operation at customer's site.Per review of risk management documents, the risk rating does not exceed candela threshold.No further corrective actions required for this complaint at this time.

• Brand Name: VBEAM PRIMA LASER SYSTEM
• Common Device Name: VBEAM PRIMA
• Manufacturer (Section D): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer Contact: greg wallender ; 251 locke drive; marlborough, MA 01752 ; 5083580463
• MDR Report Key: 20601782
• Report Number: 3016496662-2024-00005
• Device Sequence Number: 18378563
• Product Code: GEX
• UDI-Device Identifier: 00817495022963
• UDI-Public: (01)00817495022963(11)190626
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: VBEAM PRIMA
• Device Catalogue Number: 9914-00-9080
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male