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

Model Number M103P1

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Urinary Tract Infection (2120)

Event Date 03/31/2016

Event Type  Injury  

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.

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

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.

Manufacturer Narrative

This follow-up medwatch report is in response to fda report mw5062264.El en (device manufacturer) was unable to investigate this incident when initially made aware on september 26, 2016, then notified (b)(4) (us importer placed at (b)(4) united states) to which they were also unsuccessful in obtaining investigation details.El en, as the device manufacturer, decided to submit medwatch report: 3001431138-2016-00007 in response to the mw5062264 report on september 30, 2016 and subsequent follow-up report 3001431138-2016-00007 fu#1 on november 4, 2016.Fda has sent to (b)(4) the report mw5062264 on june 5, 2017 (for which (b)(4) was already aware by el en's communication and previous mdrs 3001431138-2016-00007 initial and fu#1).Cynosure notified el en accordingly on june 21, 2017.(b)(4) contacted the patient and was successful in receiving a response, now able to obtain information regarding the adverse event / treatment site.When at the laser treatment site (physicians primary care ob/gyn - (b)(6) usa), patient complained of severe pain in the bladder/urethral area from the laser procedure.But during post treatment, patient had declined any follow-up laser procedures, examinations, or medications when offered by the customer's onsite doctor.Patient then had medical intervention from a urologist upon a doctor referral due to severe pain experienced in the laser treated area.The treatment technique and actions performed for the laser procedure were not followed per the device's clinical reference guide, which was provided to the customer site with the laser device.This is because the patient in this incident was already being treated with an antibiotic medication for a yeast infection prior to the laser procedure.The patient having an "active localized or systemic infection or an open wound in area being treated" in the proposed treatment (vaginal) area prior to the procedure is contraindicated by the device's clinical reference guide and good surgery practice as per operator's manual specifications.The operator of the laser had still performed the laser procedure on the patient despite the clinical reference guide saying otherwise.The device was not evaluated since user error had contributed to this incident.Therefore, this specific case is to be classified as closed, unless fda has further questions.

• 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: 5989901
• MDR Text Key: 56008510
• Report Number: 3001431138-2016-00007
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K133895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2017

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
• Device Catalogue Number: M103P1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided; 09/26/2016
• Supplement Dates FDA Received: 11/04/2016; 07/17/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR