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	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported "multiple patients burned".The fse went to the site to evaluate the laser.Found laser had "no faults" reported from last evaluation.Fse verified that laser is performing within specifications.However, handpiece for 20 mm would not recognize in the lvm properly all the time.He verified that output energy for 20 mm was correct and laser was working properly.Suggested to exchange 20 mm handpiece and send it back to facility to try to identify intermittent connection.This condition would not cause burns and most likely would result in inability of physician to use laser when needed.Technical support will be monitoring this laser and physician was instructed to use spot testing between patients.
Event or Problem Description
On (b)(6) 2018, the advanced cardiovascular care account in us reported that patients responded to laser treatment with burns.

• 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: 7422807
• Report Number: 1218402-2018-00008
• Device Sequence Number: 709710
• 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: K140122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/11/2018
• 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