MAUDE Adverse Event Report: CANDELA CORPORATION CANDELA GMAX-PRO

Model Number	9914-00-9035
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018, (b)(4) dermatology account in us reported that patient received laser treatment for hair removal and the lens from the handpiece fell out and burned the patient with 2nd degree burn.Candela field service engineer contacted facility and ask to provide handpiece for evaluation.As of today, we did not receive it at our facility and therefore, root cause for failure is unknown.
Event or Problem Description
On (b)(6) 2018 the (b)(6) dermatology account in the us reported that during the laser treatment, the lans from the hand piece fell out and burned the patient.
Additional Manufacturer Narrative
Investigation: on (b)(6) 2018 the (b)(6) dermatology account reported that a patient received laser hair removal treatment and the lens in the hand piece fell out and burned the patient.Patient received laser hair removal treatment on the face and bikini areas.Treatment to the bikini 'v area was completed without incident.However, during treatment to the face, the internal glass.On.Ad11 the hp shattered and resulted in a burn.Account also stated that the laser had been serviced the previous day.(b)(6) qa was unable to obtain additional information pertaining to the patient/system settings, despite repeated attempts.Should additional information become available at a later date, this complaint report will be updated accordingly.On (b)(6) 2018 a (b)(6) fse evaluated the laser system and reported the following: faults logged 5.1 x 1, 6.5 x 1) saved lvm files.Cleared faults.Completed before service checklist.Calibrated both heads; alex had high tx.Verified parameters.Completed after service checklist.Saved lvm files.Laser meets all (b)(6) specifications.Conclusion / root cause: based on the information provided, the most probable root cause of reported problem can be attributed to user error: maintenance.It is possible that the distance gauge sapphire window was not properly cleaned or reinstalled correctly which would contribute to the window breaking during treatment as listed in the maintenance section of the gmax-pro operators manual.Users are instructed to check the hp windows before and during treatments.

• Brand Name: CANDELA GMAX-PRO
• Common Device Name: GMAX-PRO
• Manufacturer (Section D): CANDELA CORPORATION; 530 boston post road; wayland MA 01778
• MDR Report Key: 7503413
• Report Number: 1218402-2018-00012
• Device Sequence Number: 945385
• Product Code: GEX
• UDI-Device Identifier: 08174950200017
• UDI-Public: 08174950200017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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
• Operator of Device: Health Professional
• Device Model Number: 9914-00-9035
• Device Catalogue Number: 9914-00-9035
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other