MAUDE Adverse Event Report: CANDELA CORPORATION GENTLEMAX PRO PLUS; DERMATOLOGY LASER SYSTEM

Model Number 9914-CE-9036

Device Problems Material Perforation (2205); Unexpected/Unintended Radiation Output (4028)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2023

Event Type  Injury  

Event Description

A customer in ohio reported that as she was pulsing the laser during treatment, "there was a loud boom and smoke was coming out of the fiberglass." customer utilized the emergency shutdown button and "inspected the fiberglass to see the casing melted/burnt." there were two people in the treatment room at the time, including the patient and the customer.Both patient and customer were wearing appropriate protective eyewear when the event occurred.Customer reported that there was no injury to the patient or herself as a result of the event.Customer noted that the device has not been used since the reported event.A photo of the fiber showed a melted hole in the outer sheathing of this consumable part.The breach in the outer sheath may have resulted from a laser pulse.Per candela procedure, follow-up information was obtained from the customer.The customer confirmed that there was no injury to patient or user.The customer confirmed that everyone in the room was wearing appropriate protective eyewear when the event occurred.The questionnaire completed by customer also requested additional information about if no injury occurred at the time of the event.The customer estimated that a "life-threatening injury or permanent impairment of body function or structure" could result from the laser pulse exposure if a similar unexpected pulse were to occur again.Based on candela's complaint data, there is no history of similar reported complaints resulting in a life-threatening injury or permanent impairment of body function or structure.Therefore, this event does not meet candela's criteria for a reportable event.Due to the input from this customer, candela has decided to report this instance under 21cfr803.

Manufacturer Narrative

G4 - unable to de-select "combination product." device is not combination product a new fiber was installed, circuit calibration performed, followed by testing the new fiber.No issues were observed.Calibration verification completed, system meets all candela specifications.A break in the fiber during use would cause the reported event.Therefore, the cause for this event can be 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.

• Brand Name: GENTLEMAX PRO PLUS
• Type of Device: DERMATOLOGY LASER SYSTEM
• 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 ; 5083587400
• MDR Report Key: 17003646
• MDR Text Key: 315943779
• Report Number: 3016496662-2023-00003
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9914-CE-9036
• Device Catalogue Number: 9914-CE-9036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other