MAUDE Adverse Event Report: LUMENIS, LTD LIGHTSHEER DESIRE; SOLID STATE AESTHETIC LASER DELIVERY DEVICE

Model Number LIGHTSHEER DESIRE

Device Problems Patient-Device Incompatibility (2682); Calibration Problem (2890)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Reasonable attempts (4 emails) were made to the distributor in order to receive additional patient information, treatment settings and patient photographs of the reported event, however; only photographs were provided.A lumenis clinical director evaluated the reported patient photos concluding it appears to be a 1st degree burn, further noting there are no observable skin blisters nor skin lacerations.May take a few weeks to heal and lead to transient change of pigmentation.While the information received to date does not confirm that a serious injury occurred, because of the lack of information the company is reporting the event in an 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 Description

A foreign user facility reported that a patient sustained a post inflammatory reaction with folicle pigmentation in the leg area following hair removal treatment with a lumenis lightsheer desire laser.No information regarding a report of serious injury or medical intervention to preclude permanent impairment was received.

Manufacturer Narrative

Lumenis investigated the reported event by contacting the user facility to obtain patient information, treatment settings, and patient photographs, which were provided.An examination of the subject device by a lumenis trained technical expert concluded that upon arrival, the technical expert found the energy output to be delivering around the maximum manufacture specifications value (+20%).The technical expert reported that following recalibration of the system device and verifying all system functions including energy output verification, the subject device met required manufacture specifications.A lumenis healthcare professional evaluated the reported event details, patient photographs, and treatment settings.The healthcare professional concluded that based on the provided information the probable cause of the reported event to be operator error.Improper skin typing, aggressive treatment settings and failure to perform a test patch in contradiction to common medical practice, subject device labeling and training.Additionally, the professional noted this is not a serious injury.A review of subject device labeling states: "warning - perform test spots on patients and assess skin response before performing a full treatment.Side effects may not develop until several days following exposure.Test spot prior to treatment to determine the maximal tolerated dose for untanned skin types i-iv, wait at least 15-30 minutes after the test spot to observe tissue reaction.For skin types v-vi and acceptable tanned skin, wait at least 48-72 hours after test spots to observe tissue reaction.Always allow adequate time between test spot and actual treatment." a review of the subject device dhr confirmed that the sd met all test specifications without deviation per the dhr during the manufacturing process.

Event Description

A foreign user facility reported that one (1) female patient sustained hyperpigmentation to the legs area following hair removal treatment with a lumenis lightsheer desire laser.It was further reported that no test patch was performed prior to a full treatment.The user facility stated the patient was treated by an external dermatologist; but no information was provided by the patient to the user facility.Patient did not return for follow up visit.

• Brand Name: LIGHTSHEER DESIRE
• Type of Device: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS, LTD; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: alan vaisman ; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692 ; 49599044
• MDR Report Key: 6345671
• MDR Text Key: 67851909
• Report Number: 3004135191-2017-00021
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K151947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

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
• Device Operator: Health Professional
• Device Model Number: LIGHTSHEER DESIRE
• Device Catalogue Number: GA-1170000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR