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

Model Number LUMENIS ONE

Device Problems Energy Output To Patient Tissue Incorrect (1209); Unexpected Therapeutic Results (1631); Temperature Problem (3022)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Lumenis investigated the reported event by contacting the user facility directly by phone (3x) and by email (1x) to obtain patient information, treatment settings, and patient photographs, which have not been provided.An examination of the subject device by a lumenis technical expert has begun, but has not been completed at this time.Since no information has been provided by the user facility, a lumenis clinical director is unable to review the treatment settings for the appropriateness of treatment.Based on the information that is currently available no serious injury related to the event was reported & no medical intervention was reportedly required to preclude serious injury.In an abundance of caution lumenis is reporting this event as a malfunction which might cause or contribute to serious injury should the malfunction recur.Once a cause for the reported event has been determined, lumenis will file a follow-up mdr.

Event Description

A user facility reported that patients are complaining of increased redness and pain following treatment with a lumenis one laser, hs handpiece.Additionally the user facilities physician believes the output energy is too high.

Manufacturer Narrative

An examination of the subject device by a lumenis technical expert concluded after verifying all system functions including; calibration, energy output, the subject device operated well within manufacture specifications.Furthermore technical expert recommended replace the optic filters.Review of product dhr showed it was manufactured according to relevant procedures, tested before release according to specifications.Lumenis clinical professional concluded during similar device investigation under (b)(4): "the user did not followed instructions as per manufacture guidelines, did not check integrity before treatment and this was leading to user error." a review of lumenis one product risk file shows this is an anticipated risks (# (b)(4) in risk file (b)(4)) which has been quantified and found unlikely to lead to a serious injury if malfunction were to recur.The risks have been characterized and documented as acceptable within a full risk assessment, therefore no corrective and/or preventive actions are required.The mdr for this event had initially been reported as a product problem (malfunction).The adverse event (serious injury) was not included by human error in initial report of this event.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.Based on information above lumenis concluded that reported malfunction, has no correlation or relationship to the reported adverse event, therefore lumenis is withdrawing the malfunction claim and closing out the complaint.

• Brand Name: LUMENIS ONE
• 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: 6824683
• MDR Text Key: 84342401
• Report Number: 3004135191-2017-00119
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060448
• 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: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUMENIS ONE
• Device Catalogue Number: GAL140000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2005
• 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