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

Model Number LIGHTSHEER DUET

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 05/26/2015

Event Type  Injury  

Event Description

A user facility reported that two (2) patients sustained adverse reactions following hair removal treatment with a lumenis lightsheer duet laser.

Manufacturer Narrative

Lumenis investigated the reported events contacting the user facility to obtain patient information, treatment settings and patient photographs.Despite reasonable attempts, the facility did not provide treatment settings or patient information.Lumenis is unable to determine the severity of the patients' sequela absent relevant treatment information; therefore lumenis is submitting this medwatch report.An examination of the subject device by a lumenis technical engineer concluded the device operated to manufacturer's specifications.The engineer found the output fluence of the treatment head to be within specifications but at the high end of acceptable output.The engineer completed preventive maintenance service on the subject device concluding the system met all manufacturer specifications.

• Brand Name: LIGHTSHEER DUET
• Type of Device: SOLID STATE AESTHETIC LASER DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma street po box 240; yokneam industrial park; yokneam, israel 2069 2; IS 20692
• Manufacturer (Section G): LUMENIS, LTD.; 6 hakidma street po box 240; yokneam industrial park; yokneam, israel 2069 2; IS 20692
• Manufacturer Contact: anson kirchner ; 1870 milestone dr; salt lake city, UT 84104 ; 8775863647
• MDR Report Key: 4872010
• MDR Text Key: 5864164
• Report Number: 3004135191-2015-00042
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/26/2015

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 DUET
• Device Catalogue Number: GASB00000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2011
• 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