MAUDE Adverse Event Report: SYNERON-CANDELA CANDELA; GMAX PRO

Model Number	9914-00-9035
Medical Device Problem Codes	Sparking (2595); Flare or Flash (2942)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018 a dermatology clinic reported observing a spark.During routine follow up the clinic director reported on (b)(6) 2019 in addition to a spark, an unsustained flame was observed originating from the device fiber cable during treatment.The fiber was connected to a gmax-pro laser.It was also reported by the clinic director that there was no reported patient impact and no sustained fire.Additional information was solicited.
Additional Manufacturer Narrative
The condition of the returned device confirms that the fiber is broken.Visual analysis reveals that the handpiece and fiber show signs of a burn at the midpoint of the fiber.Signs of a velcro strap placed to hold fiber and electrical cables together during use.Burn is through the heat sheathing and fiber is snapped into two pieces.The gentlemax pro operator's manual states that the gentlemax pro laser system utilizes fiber optics that can be damaged if installed or subjected to excessive bending.To avoid damage to the fiber optics, limit bends of the fiber cable to a radius of 6 inches (15 cm) or greater.Failure to follow recommended procedures may lead to damage to the fiber cable or delivery system and/or harm to the patient or operator.When damaged, the fiber cable or delivery system becomes a potential fire hazard.Based on observation, the cause for this event can be traced to user.Candela does not provide velcro straps on fiber cables for safety reasons.Users are provided with a fiber pole to hold lines while in use.
Additional Manufacturer Narrative
Correcting adverse event to "follow-up # 2".( a corrected submission "failed" indicating: error: duplicate report is found for this supplement report ).The original correction was to modify date of report: follow-up# 1 was a supplemental report which was submitted on friday (b)(6) /2019.The date on that report was erroneously noted as (b)(6) 2019.

• Brand Name: CANDELA
• Common Device Name: GMAX PRO
• Manufacturer (Section D): SYNERON-CANDELA; 530 boston post road; wayland MA 01778
• MDR Report Key: 8353552
• Report Number: 1218402-2019-00001
• Device Sequence Number: 11313459
• Product Code: GEX
• UDI-Device Identifier: 08174950200017
• UDI-Public: 08174950200017
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2019; 05/14/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 05/17/2019; 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1