MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING S.P.A. DEKA SMARTXIDE

Model Number M079R1

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned to the manufacturer for evaluation.Distributor's authorized service personnel checked the actual suspected device unit at customer site on july 11th, 2017.Distributor's service technician evaluated the device and found it working properly within specification.The only intervention done by the service personnel concerns the refill of the coolant liquid's reservoir that is a routine maintenance intervention.The distributor reports information regarding the treatment's parameter and outcome of the two patient, as reported to him by the physician at the site.In this mdr we will focus on the patient #2.Information related to patient #1 has been reported in the mdr number 3001431138-2017-00005.The patient was treated with the smartxide laser medical device in the face area in order to perform a skin resurfacing treatment.The physician affirms that she has applied emla cream (topic anesthetic) to the face and gave 2 doses of famvir (antiviral) 30 minutes prior to the treatment.The settings of the laser were: forehead area: 25w, 200 ms spacing, 600 ms dwell; mouth area: 25w, 400 ms spacing, 1200 ms dwell.Other face's areas: 25w, 400 ms spacing, 600 ms dwell.The patient was prescribed with lenitive and antibiotic creams (cicalfate, aquaphor and prp) as normal post-treatment care.The patient called the site on (b)(6) 2017 concerned about scabbing and scarring.The patient has not followed the prescribed post-treatment care because she was only applying cicalfate.Moreover, the patient has developed a yeast infection on the face.The physician prescribed the patient with mupirocin bid, domeboro bid and diflucan q.D.For 7 days.The patient was visited for a follow-up on (b)(6) 2017 at the site and found with an improved state of healing but prescribed with domeboro bid, mupirocin bid, and diflucan q.D.For another 7 days.Another follow-up visit has been performed by the physician on (b)(6) 2017 and found significantly improved in the state of healing.The physician prescribed only ciclafate to the patient.Based on that is possible to exclude any permanent impairment to the patient.Moreover, all the treatment given to the patient following the treatment are expected post-treatment care and swelling and inflammation are forseeable side effects of laser treatments.By our internal investigation, with product manager for dermatologic application, we fund that the treatment's parameters are aggressive and the application of topic anesthetic, even if expected, exclude any possibility of the patient to give immediate feedbacks during the treatment.Moreover, the patient did not follow the prescription for post-treatment care.The investigation carried out did not conclude that a design deficiency was responsible for causing the event.Rather, it could be assumed that there was a human factors issue, where a failure of the physician to appropriately perform the treatment (aggressive parameters in combination with topic anesthetic) and a failure of the patient to follow the prescription for post-treatment care (applied only cicalfate), contributed to event.Based on the fact that the device is working within specification and that there is not any design deficiency no further remedial action are required.This initial report has to be considered as final report, unless fda has further questions.Evaluation performed by local service.

Event Description

El.En.'s has been informed by (b)(4) (u.S importer and distributor placed in (b)(4)) and became aware of an adverse event in which is involved the laser medical device smartxide model number m079r1, s/n (b)(4), manufactured by el.En.Electronic engineering (b)(4).The event have been reported to el.En.'s quality assurance personnel from (b)(4) by mail that states that, following a laser treatment two patients have developed burns and pain in the treated area.The actual laser medical device and accessory involved in this event are marketed in the us territory with premarket clearance 510(k) n° k072159.The actual date of the event is (b)(6) 2017.The name of the clinic is (b)(6).We, the manufacture of the device, became aware of the event on july the 7th, 2017 by email from (b)(4), as importer, that have already submitted an own mdr report code (b)(4) and, according to 21 cfr part 803.50(2), submitted to fda an mdr report because the event is a serious injury and patients requested medical intervention following the treatment.The present mdr report will concern patient #2.A previous mdr report code 3001431138-2017-00005 concerned patient #1.

• Brand Name: DEKA SMARTXIDE
• Type of Device: DEKA SMARTXIDE
• Manufacturer (Section D): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese 17; calenzano, firenze 50041 ; IT 50041
• Manufacturer (Section G): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese 17; calenzano, firenze 50041 ; IT 50041
• Manufacturer Contact: andrea checchi ; via baldanzese 17; calenzano, firenze 50041 ; IT 50041 ; 0558826807
• MDR Report Key: 6753247
• MDR Text Key: 81361413
• Report Number: 3001431138-2017-00006
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Service Personnel
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: M079R1
• Device Catalogue Number: M079R1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2008
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 82