MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING S.P.A. DEKA SMARTXIDE2 LASER

Model Number M103P1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994)

Event Date 02/11/2016

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned to the manufacturer's for evaluation.U.S local authorized service engineer ((b)(6)) checked the actual suspected device unit at customer site on behalf of manufacturer on july 15th, 2016.(b)(6) service technician evaluated the device for calibration and performance of laser and accessories.The deka smartxide2 unit and relevant accessories were determined to be operating properly within their specifications.No failure detected ((b)(6)).Treatment parameters, used by the physician at the time of the event, were not made available by the physician.The investigation carried out did not conclude that a design deficiency or device malfunctioning was responsible for causing the event.Rather, the injuries reported by the patient are classified as forseeable side effects of the laser treatment.In fact, the operator manual code om103p1_g.V04 (current release delivered with the medical device) in section 10.1.2 ' side effects' reports that moderate pain, blood spill, swelling (blood spill and swelling can be reconducted to serious irritation of the skin) are complication that can occur.This event is, anyway, reportable because the patient sought medical intervention from an urgent care clinic.Patient was prescribed clobetasol cream, cymbalta, and diflucan as intervention medication for post treatment care.No failure detected in the actual device evaluated.Device working within specs.Based on that, no remedial actions are required.This initial report is to be considered as final report, unless fda has further questions.Evaluation performed by local service.

Event Description

North america importer/distributor, (b)(6) located in (b)(6) usa, noticed us about an adverse event they recently became aware of.Involved device was deka smartxide2 model number m103p1, s/n (b)(4), manufactured by el.En.Electronic engineering (b)(4).The actual date of event is (b)(6) 2016 and (b)(6) became aware of this incident on august 7th, 2016.Event took place in the united states territory at (b)(6), usa.(b)(6) investigator collected information from customer and informed us that one deka smartxide2 was involved in laser treatment on patient who developed irritation and pain.Moreover he informed us that after the treatment with the deka smartxide2 device the patient received medical intervention from an urgent care clinic.Patient was prescribed clobetasol cream, cymbalta, and diflucan as intervention medication for post treatment care.(b)(6) have submitted an mdr report, concerning this event, for the laser medical device involved, on august 3rd,2016: report (b)(4) for the deka smartxide2 device as importer.The manufacturer of this device is el.En.Electronic engineering (b)(4) we, the manufacturer of device deka smartxide2 , became aware of the event on july 18th, 2016 by email from (b)(6) and, according to 21 cfr part 803, el.En.Electronic engineering (b)(4) submitted to fda an own initial 30 days mdr report for the deka smartxide2 device for which el.En electronic engineering (b)(4) is the manufacturer.This event is reportable to fda, on the side of caution, because the patient received medical intervention to avoid a permanent impairment of a body structure.

• Brand Name: DEKA SMARTXIDE2 LASER
• Type of Device: DEKA SMARTXIDE2 LASER
• 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: 5846168
• MDR Text Key: 51131709
• Report Number: 3001431138-2016-00006
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/04/2016

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: Physician
• Device Model Number: M103P1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2015
• 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