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	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility.Three (3) attempts have been made by one (1) phone call and two (2) emails to obtain; patient treatment settings, patient information, patient photos.No information has been provided by the user facility.Lumenis received information from (b)(4), a distributor head engineer who confirmed that the customer wasn't pleased from the new hs handpiece they bought.They reported it wasn't working as expected.A certified engineer from (b)(4), the distributor, visited the facility and did not detect any problem with the handpiece.The customer wanted a new hs handpiece anyway.The engineer concluded that after verifying all system functions including calibration and energy output verification, the subject device operated well within manufacturer specifications.No device malfunction was observed.No clinical evaluation was done, as no incident forms were sent to lumenis.Lumenis is reporting this adverse event to fda in abundance of caution.Should additional information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Event or Problem Description
A foreign user facility reported on a few patients who sustained a burn of unknown severity to an unknown anatomical area following treatment with a lightsheer duet laser.No report of serious injury or medical intervention has been received except for the initial report from the user facility.This complaint represents all patients as no information was received by the facility on the patients.

• 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: 8564619
• Report Number: 3004135191-2019-00051
• Device Sequence Number: 13979017
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 7290109140483
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: LIGHTSHEER DUET HS/ET
• Device Catalogue Number: GASB00000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/30/2019
• 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: Other