MAUDE Adverse Event Report: CANDELA CORPORATION ETWO SKIN TREATMENT SYSTEM; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number FG70502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/07/2023

Event Type  Injury  

Event Description

A customer in italy reported an unanticipated tissue response when providing a photo rejuvenation treatment on a female patient with the etwo system sublime applicator.A photo was provided to support the complaint.The photo was reviewed with candela sr.Director, global clinical operations.As the degree of impact, depth of injury, and level of impairment could not be fully evaluated given insufficient information and poor picture quality, candela is erring on the side of caution and reporting the event.Additional information was solicited.Per follow up, the customer reported a second-degree burn to the patient's right cheek following a single pass at 70 joules.The patient felt a "strong heating with immediate visible white burn." treatment was stopped, and an ice pack and cold water applied "right away." the customer changed the energy to 50 joules and treated the left side of the patient's face with no issue.Customer reported that the patient had no recent sun exposure and noted that a test spot was performed.The patient injury was treated with zinc cream immediately after treatment, followed by connettivina plus cream and topical medication with connettivina gauzes.The customer reported that the patient is "doing much better," the injuries have improved.

Manufacturer Narrative

Candela service engineer went onsite to evaluate the device; performed service test form, general check, and functional test.Service engineer found "device is working properly." case investigation pending.

Manufacturer Narrative

Field service engineer (fse) evaluation indicates that there is no issue with the device in question.Based upon evaluation by the fse, the system would not have contributed to the reported event.There is nothing to indicate that the device was not used in accordance with treatment guidelines.However, the etwo user's manual states the following for possible side effects: improper use of the system could result in possible side effects.Although these effects are rare and expected to be transient, any adverse reaction should be immediately reported to the physician.Side effects may include any of those conditions listed below.Side effects may appear either at the time of treatment or shortly after.Some dark-skinned patients may have a delayed response one-to two days after treatment and should be evaluated post-test spot accordingly.The side effects may include: damage to natural skin texture (crust, blister, burn).This indicates that burns are an expected result of treatment or operation of the device.Therefore, the cause for this event is known inherent risk to device, indicating that the reported adverse event is known and documented in the labeling (including both short or long term known complications or adverse reactions).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: ETWO SKIN TREATMENT SYSTEM
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer (Section G): NPA DE MEXICO, S. DE R. L. DE C.V.; sor juana inez de la cruz.; no. 20150 int. 5, ciudad indus; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: chaz weyer ; 251 locke drive; marlborough, MA 01752 ; 5083587400
• MDR Report Key: 18365021
• MDR Text Key: 331001770
• Report Number: 3016496662-2023-00008
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141507
• 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: 01/18/2024

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 Catalogue Number: FG70502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/18/2024
• 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
• Patient Sex: Female