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U.S. Department of Health and Human Services

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

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EL.EN. ELECTRONIC ENGINEERING S.P.A. DEKA SMARTXIDE2 LASER Back to Search Results
Model Number M103P1
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/11/2016
Event Type  Injury  
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.

 
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.

 
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Brand NameDEKA SMARTXIDE2 LASER
Type of DeviceDEKA SMARTXIDE2 LASER
Manufacturer (Section D)
EL.EN. ELECTRONIC ENGINEERING S.P.A.
via baldanzese 17
calenzano, firenze 50041
ITALY 50041
Manufacturer (Section G)
EL.EN. ELECTRONIC ENGINEERING S.P.A.
via baldanzese 17
calenzano, firenze 50041
ITALY 50041
Manufacturer Contact
andrea checchi
via baldanzese 17
calenzano, firenze  50041
ITALY   50041
0558826807
MDR Report Key5846168
Report Number3001431138-2016-00006
Device Sequence Number1
Product CodeGEX
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
Date FDA Received08/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device MODEL NumberM103P1
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/08/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/04/2016 Patient Sequence Number: 1
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