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

Model Number FG70534

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

A supplemental mdr will be filed upon completion of the investigation.

Event Description

Customer reported a (b)(6) year-old female patient with skin type 2 had intense pulsed light (ipl) photo facial on (b)(6) 2019.Following treatment, patient showed minimal erythema on all areas other than nose which showed mild erythema.Customer reports that the patient emailed trilogy medical center on (b)(6) 2019 with a complaint about a burn on right cheek bone area and concerned that it may be infected.The patient contacted an rn in her area (she lives out-of-state) and was prescribed mupirocin ointment 4 times daily for 10 days.The trilogy treatment provider sent customer elta laser enzyme gel to use am/pm until burn heals and reminded patient to wear daily spf and avoid sun exposure.Customer reports burn will heal but is predicted to scar.This was the patient's third treatment, most recent prior treatment was (b)(6) 2019 with no adverse reactions.No reported recent sun exposure.Test spot was performed with 16j, 22rf.

Manufacturer Narrative

Field service engineer evaluated unit in response to the reported patient impact and found unit to be operating within specifications with no faults or problems identified.Reported treatment parameters are within guidelines; however, not all parameters were reported.Customer did not use the (b)(6) supplied coupling gel.The elos plus system user manual provides the following warning: only use coupling gel supplied by (b)(6).Coupling gels from other manufacturers may perform inadequately and may be the cause of damage to the patient's skin.Because the reported adverse event is known and documented in the labeling (including both short or long term known complications or adverse reactions), the complaint conclusion is known inherent risk of device.No new risks or hazards identified with this complaint.

• Brand Name: ELOS PLUS
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNERON MEDICAL LTD.; inductrial zone po box 550; yokneam, 20692 0; IS 206920
• Manufacturer (Section G): SYNERON MEDICAL LTD.; inductrial zone po box 550; yokneam, 20692 0; IS 206920
• Manufacturer Contact: yverre bobay ; 530 boston post rd; wayland, MA 01778
• MDR Report Key: 9296745
• MDR Text Key: 165638639
• Report Number: 3003772750-2019-00005
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG70534
• Device Catalogue Number: FG70534
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR