MAUDE Adverse Event Report: CYNOSURE ELITE

Catalog Number R100-7000-010

Device Problem Output below Specifications (3004)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Technician determined that repairs to the lamps, beam combiner, and calport sapphire window were needed to resolve the device's issue.Patient had an alleged burn, but this could not be confirmed with the customer site as they were unresponsive to multiple requests for patient/treatment details.This event is an aro (accidental radiation occurrence) because the device was operating out of specification range.Therefore, this event is reportable.

Event Description

The device was found to be delivering a laser energy output 40% below specification.

• Brand Name: ELITE
• Type of Device: ELITE
• Manufacturer (Section D): CYNOSURE; 5 carlisle road; westford MA 01886
• Manufacturer Contact: 5 carlisle road; westford, MA 01886
• MDR Report Key: 7785961
• MDR Text Key: 117275290
• Report Number: 1222993-2018-00017
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: R100-7000-010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2018
• 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