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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 Insufficient Information
Event Date 03/31/2016
Event Type  Injury  
Event Description

On september 26th, 2016, el. En. Electronic engineering (b)(4) became aware of an adverse event, reported by one patient to the fda, through the medwatch system. The patient, mrs (b)(6), reported to the fda, on may 12th, 2016, an adverse event happened to her, following what she describes as a "vaginal rejuvenation treatment", performed by her gynecologist with the "monalisa touch laser", on (b)(6) 2016. With high degree of confidence, the medical device involved in this event is the deka smartxide2 laser, because this is the only medical device marketed in the usa, to perform the "monalisa touch" procedure, at the time the patient received the treatment. El. En. Electronic engineering (b)(4) is the manufacturer of the deka smartxide2 laser medical device, cleared by fda under 510(k) k133895. The patient reported that, the day after the treatment, she developed a severe and debilitating bladder/urethral pain. In the following 2 weeks, she was twice visited by the gynecologist, who had performed the treatment, having also urinalysis, always with negative responses. Then the patient changed gynecologist and this new gynecologist was treating her, at the time she submitted the report, with vagifem, which is however medication to treat gsm symptoms and definitely not the primary care for the symptoms that the patient reported. So, there may be additional clinical information, which we may lack, in this particular event. The bladder/urethral pain reported by the patient might be compatible with a form of uti, even if, with the information in our hand, it is impossible to prove it. As per the operator's manual (p/n om103p1_g. V08) of the laser and the monalisa touch clinical reference guidelines (p/n 921-7030-000, rev. 03), both pain and infections may be foreseeable side effects of the treatment. Fda communicated this event to (b)(4), us importer of the medical device, on july 25th, 2016, but the letter was only received few days ago. Then, el. En. Electronic engineering (b)(4), the manufacturer, has been informed via email, by (b)(4) (us importer), on september 26th, 2016, only. We suspect that the patient saw the brand name of the laser (deka) and put it in the "manufacturer" field of the report, where it is, in fact, only specified "deka". Then, the fda sent the communication to the us importer, (b)(4) and not to el. En. Electronic engineering (b)(4). Also, the main distributor of this medical device in the usa is (b)(4), which is the official us importer for this device, too.

 
Manufacturer Narrative

The event has been reported by the fda to the us importer, (b)(4), via mail, following an adverse event reported by one patient through the medwatch program (report code mw5062264). The communication to the us importer has been forwarded by the fda on july 25th, 2016. The us importer forwarded the information to el. En. Electronic engineering (b)(4), manufacturer of the smartxide2 laser, on september 26th, 2016, via email. El. En. (b)(4) decided to submit this initial mdr to the fda, as soon as it received the information from the us importer (b)(4) and also started an investigation into this event, with the support of (b)(4), which is the official us importer and distributor of this medical device in the usa. At this time, this is the only information el. En. Electronic engineering (b)(4) has, regarding this event. The investigation has just started and has not given any further results, yet. El. En. Electronic engineering (b)(4) will of course submit a follow-up report to the fda, with any additional information that could be found, during such investigation. Device not available at the time.

 
Manufacturer Narrative

Since the actual device was not returned to the manufacturer, a direct investigation on the device could not be performed. Based on the information provided in the medwatch program report code mw5062264, el. En. (b)(4), as manufacturer of the suspect laser medical device involved in the adverse event happened to ms. (b)(6), have attempted to contact the patient by phone and by email (the only contact details expressed in the mw5062264 report). Also the us importer, (b)(4). , was involved in the attempt to contact ms. (b)(6) in order obtain any additional information for the investigation. All the attempts to contact ms. (b)(6), done by both el. En. And (b)(4), have failed. Infact the email address provided in the report mw5062264 could not be reached by e-mail providers and she did not ever answered the phone and no voicemail was present in order to leave a message. Throughout october 2016, (b)(4) and el. En. Have done n°3 attempts to contact ms. (b)(6) by email and n°3 attempts to contact her by phone without any success nor reply. Based on the information above mentioned is impossible to investigate on this case any further. El. En. Will remain vigilant with increased level of attention on this matter. Therefore, this specific case is to be classified as closed, unless fda has further questions.

 
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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 Key5989901
Report Number3001431138-2016-00007
Device Sequence Number1
Product CodeGEX
Report Source Manufacturer
Source Type OTHER
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 07/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device MODEL NumberM103P1
Device Catalogue NumberM103P1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2016
Was Device Evaluated By Manufacturer? No
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: 09/30/2016 Patient Sequence Number: 1
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