MAUDE Adverse Event Report: LUMENIS, LTD RESURFX; RESURFX SYSTEM

Model Number RESURFX

Device Problems Unexpected Therapeutic Results (1631); Device Issue (2379)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

A review of the subject device service records found the system had recently been serviced by a lumenis certified technician within (1) one month of the event date.Upon completion of the service visit, the system was tested and found to operate within specifications and safe to use.A lumenis clinical manager reviewed the photographs of the post-treatment patient, and concluded "excess energy resulted in pin-point petechiae.A test spot should always be performed before treatments, especially following servicing a system.Adequate time should be given between test patches and actual treatment in order to review the skin's response.The condition is transient and should resolve within ~2 weeks.Sun avoidance is advised and sun screen should be applied daily." absent patient data and treatment settings, the clinical director was unable to evaluate the appropriateness of the settings.While the information received to date does not suggest that a malfunction occurred, because of the lack of information the company is reporting the event in an abundance of caution.Once additional information becomes available, the complaint record will be updated accordingly, and a follow up medwatch report will be submitted.

Event Description

A foreign user facility reports that (3) three patients got petechiae immediately following a resurfx treatment.No report of serious injury or medical intervention to preclude permanent impairment were received.

Manufacturer Narrative

***additional information (b)(6) 2018.A review of device labeling um-1024721 states the following: 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.For skin type v, wait at least 48-72 hours after test spots to observe tissue reaction.Always allow adequate time between test spot and actual treatment.Subject device was received at lumenis ltd.And based on performed investigation a lumenis quality engineer concluded by stating, "system passed full testing session in r.H.- no malfunction\deviations were identified".Based on the information above, lumenis is withdrawing the malfunction claim, has changed the device, method, result, conclusion codes in block h6 of this report and closing the complaint.

• Brand Name: RESURFX
• Type of Device: RESURFX SYSTEM
• Manufacturer (Section D): LUMENIS, LTD; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 6343781
• MDR Text Key: 67994695
• Report Number: 3004135191-2017-00018
• Device Sequence Number: 1
• Product Code: ONG
• Combination Product (y/n): N
• PMA/PMN Number: K130028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RESURFX
• Device Catalogue Number: GA-1006169
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1