MAUDE Adverse Event Report: CYNOSURE INC ICON

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

Cynosure technician inspected the unit and found it was out of specification.The energy output was 20% less than laser's nominal energy.Low energy was due to repairs needed to the handpiece.The machine also did not trigger an error message to alert the user.This is reportable because the customer's laser was operating out of specification.

Event Description

The laser device was found operating out of specification during the service evaluation and did not trigger an error message to alert the user.

• Brand Name: ICON
• Type of Device: ICON
• Manufacturer (Section D): CYNOSURE INC; 5 carlisle rd; westford MA 01886
• Manufacturer (Section G): CYNOSURE INC; 5 carlisle rd; westford MA 01886
• Manufacturer Contact: 5 carlisle rd.; westford, MA 01886 ; 9783678736
• MDR Report Key: 5100404
• MDR Text Key: 26625351
• Report Number: 1222993-2015-00041
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K110907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2015
• 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: N
• Patient Sequence Number: 1