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

Model Number M103P1

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

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

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned to the manufacturer for evaluation.Us importer's authorized service personnel checked the actual device unit at customer site on december 11th, 2017.The technician found, prior to any servicing operation, the device to be working properly within specifications ((b)(4)).The investigation has been performed by interrogating the doctor that have performed the treatment, dr.(b)(6).The operator of the device (site doctor) stated that the treatment procedure was performed per the clinical reference guide protocol.Moreover site's doctor did indicate the patient has a history of cystitis, long standing urethral pain prior to the laser procedures, was on numerous medications for +25 years (such as elmron, amytripyline, loprezol, atosvastatin, gabapentin, valium, oxycodone, pro-biotics, calcium, vitamin d) , and was looking for urethra pain management treatments.However the patient declined to follow up with the customer site, so there is no additional information regarding the treatment from this event.The investigation carried out did not conclude that a design deficiency or device malfunctioning was responsible for causing the event.Rather, it could be assumed that there was a pre-existing patient's condition that contributed to the event.Device working within specifications.No remedial action required.This initial report is to be considered as final report, unless fda has further questions.

Event Description

The patient contacted the manufacturer through the general contact mail in date (b)(6) 2017 reporting of an adverse event following a treatment with smartxide2 laser medical device (ref: m103p1 - s/n: (b)(4)) manufactured by el.En.Electronic engineering (b)(4).The patient described that she saw an urologist because she was having burning in her urethra following 4 laser treatment performed by doctor (b)(6) at the clinic "advanced urology manhasset" placed at (b)(6).That patient saw 2 different urologist and received medical intervention from them after the laser treatments.The manufacturer have involved its us importer, (b)(4) company located in (b)(4), in order to carry the investigation in the united states.The us importer has been informed the same day that the manufacturer became aware of the event ((b)(6) 2017).(b)(4).Also represents us distributor and service center for el.En.Electronic engineering (b)(4) medical devices.The us importer have contacted both patient and physician in order to deeply investigate on this issue.Unfortunately the patient did not agreed to release her clinical data for evaluation.This incident was classified as a reportable event by the us importer because the patient had medical intervention following the treatment.The us importer, (b)(4), submitted an mdr initial report to fda for this event (#1222993-2017-00050) on december, 15, 2017.This medwatch report is in response to fda report mw5073422 submitted to fda by the patient in date (b)(6) 2017 and received by fda in date (b)(6) 2017.In conformity to 21 cfr part 803.22(a) el.En.Will submit only one mdr because the information incoming from different sources (the patient and fda) concerns the same event.We, the manufacturer of device, became aware of the event on (b)(6) 2017 by email from the patient and, according to 21 cfr part 803.50(b)(2), submitted to fda an own mdr report in order to conduct an investigation of the event and to obtain missing or incomplete information provided by the importer.

Manufacturer Narrative

The present follow-up report has been prepared as a response to the medwatch report #mw(b)(4).The mw(b)(4) concern the same event happened in 2017 and reported to the manufacturer by fda with medwatch report mw(b)(4).Based on that, in accordance with fda 21 cfr part 803.22(a) the present follow-up report have been prepared in order to submit the additional information gathered.In fact, cynosure (us importer) have been made aware of the medwatch report mw(b)(4) and requested to contact the patient to have additional information.The patient has been contacted by the us importer and it is confirmed that the mw report mw(b)(4) is related to the same event happed in 2017 and reported by the patient to the fda with medwatch report mw(b)(4).The patient (that have history of chronic urethral pain for more than 25 years), who is seeking medical care from a urologist, now claims of nerve damage in the laser treated area.The treatment care for the patient's condition included a combination of prescription and otc medications for pain management (pain medications, otc medication/vitamins, medical marijuana), and a nerve block injection by the urologists.This evolution of her pathology has been treated with pain meds.Additional information confirmed that the root cause of the event is the same as per 2017: the pre-existing condition (chronical urethral pain) of the patient caused the event.This report has to be considered as a final report unless fda has further questions.

Event Description

On march the 1st, 2019 el.En.Electronic engineering s.P.A became aware of a medwatch report #mw(b)(4) through our us agent, emergo.In the medwatch report the patient reported that she is suffering from urethral pain and under treatment with pain medications.The patient name is (b)(6).The patient already submitted a medwatch report in 2017 #mw(b)(4) for which el.En.Spa submitted the initial mdr in date december the 18th, 2017.The information available with the new mw report were communicated to cynosure inc.(us importer) in order to contact the patient.Cynosure contacted the patient and found that the event reported by the patient is the same as per 2017.Based on the information gathered by the us importer, related to the event, we decide to submit a follow-up report to the mdr in accordance to fda 21 cfr part 803.22(a).Moreover the us importer submitted their own mdr #mdr 1222993-2017-00050 fu#1 and el.En.In accordance to fda 21 cfr part 803.50(2) decide to submit an own mdr.The present mdr is in response to medwatch report #mw(b)(4).

• Brand Name: DEKA SMARTXIDE2
• Type of Device: DEKA SMARTXIDE2
• Manufacturer (Section D): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese 17; calenzano, firenze 50041 ; IT 50041
• MDR Report Key: 7125417
• MDR Text Key: 95182316
• Report Number: 3001431138-2017-00009
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

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: Health Professional
• Device Model Number: M103P1
• Device Catalogue Number: M103P1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other