MAUDE Adverse Event Report: LUMENIS LTD. LIGHTSHEER DUET TOP ASSY; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number	LIGHTSHEER
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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.Attempts have been made by mail to obtain; patient treatment settings, patient information, patient photos.However, lumenis received only photos without incident forms, and the photos were not identified with location, so it was not possible to ascertain much from the photos.The distributor indicated that they had requested but not received from the sites more information such as documentation photos and protocols.Furthermore, despite mentioning "several" cases of burn, since no incident forms were received, only 1 complaint will be opened per site.Furthermore, no service report was sent to lumenis by the distributor, despite requests for such.As a result, lumenis can't conclude on a device malfunction.The system was returned and will be evaluated.While the information received to date does not confirm that a serious injury occurred, due to the lack of information regarding the injury leaving a permanent impairment, the company is reporting the event in an "abundance of caution".The root cause of the adverse event is not clear.Should significant 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 distributor reported that their customer was claiming several cases of burn during vascular treatment with a lumenis lightsheer device.No report on a serious injury was received.The original mail from the distributor to the eu ndc representative ((b)(6)) mentioned several other issues at other sites as well, however, mr.(b)(6) indicated that the other issues were just technical questions which he answered and that there were only 3 actual complaints on splendor x systems at 3 different sites and this complaint on a lightsheer system at a separate site.Thus 4 pc's were opened, one for each site and case reported.

• Brand Name: LIGHTSHEER DUET TOP ASSY
• 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: 10688597
• Report Number: 3004135191-2020-00072
• Device Sequence Number: 16964337
• Product Code: GEX
• UDI-Device Identifier: 07290109140483
• UDI-Public: 7290109140483
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K170179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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
• Device Catalogue Number: GASB00000GR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2020
• 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