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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.
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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.
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