MAUDE Adverse Event Report: EL. EN. ELECTRONIC ENGINEERING SPA CYNOSURE CELLULAZE - SLT II; ND: YAG LASER

Catalog Number	105-0056-810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Patient Problem/Medical Problem (2688)
Date of Event	04/19/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was made aware that a patient death occurred following a laser treatment on the thighs area.This claim was made by the patient's brother who indicated that the death was due to bleeding.However, the customer site stated the patient's laser treatment had proceeded normally and her blood pressure was in good standing.The customer site stated that the patient did not show up for any follow up checkups.Prior to the laser treatment, it was disclosed that the patient was currently taking antidepressant medications.Patient was also given alprazolam orally for sedation and lidocaine/epinephrine for tumescent anesthesia as part of the pre-treatment activities.There was no additional information provided by the customer site regarding the patient's death or treatment procedure.The device was evaluated and found to be operated as intended within specification.One of the expected side effects from an slt ii laser procedure is bleeding, but due to limited information available, a relationship between the patient's death and procedure could not be determined from this investigation.This is a reportable event due to a patient death.
Event or Problem Description
A patient had died following a laser procedure with the slt ii device.

• Brand Name: CYNOSURE CELLULAZE - SLT II
• Common Device Name: ND: YAG LASER
• Manufacturer (Section D): EL. EN. ELECTRONIC ENGINEERING SPA; via baldanzese 17; calenzano, italy 50041 ; IT 50041
• MDR Report Key: 8313178
• Report Number: 1222993-2019-00003
• Device Sequence Number: 2119953
• Product Code: OYW
• UDI-Device Identifier: 08057017760009
• UDI-Public: (01)08057017760009(11)170414
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2019
• Report Date (Section F): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 105-0056-810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2019
• Event Location: Home
• Date Report to Manufacturer: 02/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2019
• 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: Death
• Patient Age: 52 YR
• Date Report Sent to FDA: 02/06/2019