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

Model Number	LIGHTSHEER DUET
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 distributor directly.Lumenis contacted the facility in order to obtain; patients' treatment settings, patients' information, patients' photos which yet to be sent.A lumenis service engineer visited the site and analyzed the device.The service engineer found a problem with the pattern given by the hs handpiece.The pattern was not normal the hp was replaced and was requested to be sent to israel for further investigation.No incident forms were received, therefore no clinical evaluation was done in order to determine the severity of the injury.Lumenis is currently investigating the reported event.The hp is on its way to israel for further investigation.The failure in the diode array is not seen as likely to lead to death or serious injury should it to recur (learned from past diode array defects complaints).While the information received to date does not confirm that a serious injury occurred, because of the lack of information regarding the injury, 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
A foreign distributor reported on two (3) patients sustained burns following treatment with lumenis lightsheer duet hset.This patient sustained a burn to the legs.This complaint represents all 3 patients as no incident forms received.

• 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: 10841519
• Report Number: 3004135191-2020-00082
• Device Sequence Number: 17076815
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 07290109140483
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2020

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
• Device Catalogue Number: GASB00000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/15/2020
• 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