MAUDE Adverse Event Report: LUMENIS LTD. LIGHTSHEER DUET HS/ET; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER DUET HS/ET
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility by phone to obtain the incident form, photos, and more information.No incident form or photos were required as no actual injury occurred.A lumenis service engineer visited the site and upon arrival found no errors at startup.Performed troubleshooting and found a loose connection on hs handpiece to head connector causing communication errors.Ce also found burnt spot on hs heat output.Replaced hs handpiece, performed calibration, and tested energy output.Works well per specifications and ready for use.The service engineer is on vacation after the 30 days reporting time, therefore there is no clear answer whether the hs failure was connected to the safety issue which in the end resulted without an actual injury.No incident forms were required as no patient injury occurred.Based on the information received to date the adverse event resulted without an injury.Nevertheless, the service engineer found some defects with the hs handpiece which might potentially cause an injury.Due to the lack of information if the hs defect is related to the risk of injury lumenis is reporting the event in an 'abundance of caution'.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.The company is reporting the event in an abundance of caution.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained burn marks following treatment with a lightsheer duet device.Reported that while using the hs handpiece a hole was made to the side of the tip and that message appeared regarding the handpiece not being connected/recognized.

• Brand Name: LIGHTSHEER DUET HS/ET
• Common Device Name: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 10923255
• Report Number: 3004135191-2020-00083
• Device Sequence Number: 14517662
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 7290109140483
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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 Model Number: LIGHTSHEER DUET HS/ET
• Device Catalogue Number: GASB00000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1