MAUDE Adverse Event Report: LUMENIS, LTD. M22; INTENSE PULSE LIGHT DELIVERY DEVICE

Model Number M22

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem Burn(s) (1757)

Event Date 02/17/2017

Event Type  Injury  

Manufacturer Narrative

Lumenis investigated the reported event by contacting the user facility directly.Attempts have been made by phone to obtain; patient treatment settings, patient information, patient photos, and sun exposure.No information has been provided by the user facility.An examination of the subject device by a lumenis technical expert concluded that upon arrival the technical expert found the ipl handpiece to be delivering approx.20% higher energy than the display screen settings.Following preventative maintenance and performing energy calibrations, the technical expert stated that the subject device met all lumenis manufacture specifications and was returned back to service at the user facility.Lumenis is continuing its investigation.When additional information becomes available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.

Event Description

A user facility reported that one (1) patient sustained a burn of unknown severity to an unknown anatomical area following ipl treatment with a lumenis m22 laser.No report of serious injury or medical intervention has been received except for the initial report from the user facility.

Manufacturer Narrative

A lumenis quality engineer reviewed the reported event details and concluded by stating, "although the handpiece energy deviated from the desired value, it was within the safety requirement of +/- 20% energy deviation." additionally, the quality engineer consulted with a lumenis clinical affairs manager who stated, "such deviation although outputting higher energy is within the safety limits, furthermore the user is required to make a test patch to ensure no adverse event happening." the quality engineer concluded that the subject device operated within lumenis specifications and that the reported event is not due to a system malfunction.A review of device labeling found the following caution: "the energy output of a treatment head decreases over time.Thus, if calibration is performed after a long time interval, the energy emitted after the calibration may be higher than before the calibration, for the same setting.Make sure to perform a test patch before starting treatment.".

• Brand Name: M22
• Type of Device: INTENSE PULSE LIGHT DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma street; po box 240; yokneam industrial park, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS, LTD.; 6 hakidma street; po box 240; yokneam industrial park, 20692 ; IS 20692
• Manufacturer Contact: brett godfrey ; 1870 south milestone drive; salt lake city, UT 84104 ; 8016562663
• MDR Report Key: 6424975
• MDR Text Key: 70581242
• Report Number: 3004135191-2017-00036
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083733
• 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,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M22
• Device Catalogue Number: GA-0005200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2012
• 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): Congenital Anomaly; Other