MAUDE Adverse Event Report: SYNERON MEDICAL LTD. ELOS PLUS; POWERED LASER SURGICAL INSTRUMENT

Model Number	FG70533
Medical Device Problem Codes	Calibration Problem (2890); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Scar Tissue (2060); Skin Inflammation/ Irritation (4545)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results are pending.A supplemental report will be filed as required.
Event or Problem Description
A customer reported that a (b)(6) female patient had a full face "fotofacial" treatment using the elosplus sra handpiece on (b)(6) 2021.The customer also reported that the patient had no prior sun exposure.Prior history of aesthetic treatment includes neuromodulators and a prior "fotofacial." a test spot was performed to the right lower face with a tissue response of erythema noted.Customer reported using multiple treatment settings throughout the procedure, adjusting settings based upon observation of skin reaction."during treatment, mild to moderate erythema was apparent in striped pattern." customer reported an immediate post-treatment reaction of "linear erythema patterns, grayish hue to skin." customer noted, "within 18 hours after treatment, patient called clinic with complaints of blisters approximately one (1) inch in length and circular blisters along treatment patterns." the patient was provided with an immediate in-clinic assessment.Wound care, debridement, and topical bacitracin ointment were provided.No prescription medications were prescribed.Reported blisters, micro crusting, and striping were resolved when the patient was seen two months post treatment.Customer reported patient has a depressed, erythematous linear scar to right cheek and that it is "unknown if full healing will take place." candela has decided to report this event to err on the side of caution due to the "unknown" nature of healing.
Additional Manufacturer Narrative
Candela field service engineer evaluated the device and determined that the optics were not in range between the system and test meter with both laser and intense pulsed light (ipl) handpieces.The cause for this event is traced to component failure.Review of risk management documents demonstrate that the reported risk is captured and assessed and is an expected or random component failure without any design or manufacturing issue.No further corrective actions required for this complaint at this time.Risk information is then subject to periodic risk reviews and trend tracking.

• Brand Name: ELOS PLUS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNERON MEDICAL LTD.; tavor building p.o box 550; yokneam,illit, northern 20692 ; IS 20692
• Manufacturer (Section G): SYNERON MEDICAL LTD.; tavor building p.o box 550; yokneam,illit, northern MA
• Manufacturer Contact: greg wallender ; 251 locke drive; marlborough, MA 01752 ; 5083587400
• MDR Report Key: 13061062
• Report Number: 3003772750-2021-00005
• Device Sequence Number: 1506186
• Product Code: GEX
• UDI-Device Identifier: 07290109950891
• UDI-Public: (01)07290109950891(11)200105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: FG70533
• Device Catalogue Number: FG70621
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female