MAUDE Adverse Event Report: CYNOSURE LLC ELITE+

Catalog Number	100-7018-010
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the contract manufacturing site reporting an unintended discharge of laser energy, this event is an aro (accidental radiation occurrence) and therefore reportable.
Event or Problem Description
On 24 apr 2024, contract manufacturer cogmedix reported to cynosure an accidental radiation occurrence (aro), which occurred during the manufacturing assembly process of elite+ sn (b)(6) on 16 feb 2023.During the assembly process, the yag rod was installed backwards and caused the laser to fire backwards unexpectedly.No injuries were reported.Per the procedure, a protective shield is to be used during the assembly process and it was not being used at the time of the reported incident.Cogmedix has initiated corrective action ca-100634 to address this issue.

• Brand Name: ELITE+
• Common Device Name: ELITE+
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer (Section G): COGMEDIX; 127 hartwell st; west bolyston MA 01583
• Manufacturer Contact: nirav desai ; 5 carlisle road; westford, MA ; 9783940763
• MDR Report Key: 19226121
• Report Number: 1222993-2024-00021
• Device Sequence Number: 8320809
• Product Code: GEX
• UDI-Device Identifier: 00841494100063
• UDI-Public: (01)00841494100063(11)230203
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 100-7018-010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown