MAUDE Adverse Event Report: LUMENISLTD LIGHTSHEER DESIRE; INTENSE PULSE LIGHT DELIVERY DEVICE

Model Number	LIGHTSHEER DESIRE
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	Burning Sensation (2146)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility by phone or mail to obtain more information, incident form, and photos which weren't sent as the facility representative mentioned the patients weren't injured at all.An examination of the subject device was done by a lumenis service engineer after verifying all system functions.He tried calibrating the handpiece.The energy was still too high.He replaced the computer board but the computer board that was shipped did not work.There is still no conclusion as the investigation is still ongoing, and it's not clear if this could lead to serious injury.No clinical evaluation was required as the facility rep.Said the patients didn't sustain any burns only redness that resolved on its own in one case and resolved with a topical ointment.While the information received to date confirms that no injury had occurred, the case is still under investigation.As per potential injury, if it were to recur, currently it is being assumed that it can cause a serious injury.This will be further investigated by a technical evaluation of the system in order to confirm if serious injury really can occur if this issue were to recur.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.
Event or Problem Description
Lumenis received an adverse event report on two patients who sustained burns at the bikini and upper leg areas following treatment by lightsheer desire device.This complaint represents both patients as no patient incident forms were sent.

• Brand Name: LIGHTSHEER DESIRE
• Common Device Name: INTENSE PULSE LIGHT DELIVERY DEVICE
• Manufacturer (Section D): LUMENISLTD; 6 hakidma street; yokneam, 20692 ; IS 20692
• MDR Report Key: 11620803
• Report Number: 3004135191-2021-00022
• Device Sequence Number: 4365080
• Product Code: GEX
• UDI-Device Identifier: 07290109140384
• UDI-Public: 07290109140384
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/06/2021

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 DESIRE
• Device Catalogue Number: GA-1170000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1