MAUDE Adverse Event Report: EL. EN. ELECTRONIC ENGINEERING SPA DEKA SMARTXIDE2 LASER

Catalog Number 105-7030-100

Device Problems Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

This initial medwatch report is in response to fda report mw5062264 and following el en spa's medwatch report: 3001431138-2016-00007.(b)(4) (importer) was unable to investigate this incident when initially made aware on october 4, 2016, then notified el en (device manufacturer) 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.(b)(4) was once again made aware of fda report mw5062264 on june 5, 2017 and notified el en accordingly.(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, 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.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.This updated information supplements medwatch report: 3001431138-2016-00007 and responds to the fda report mw5062264.

Event Description

Patient had medical intervention following a laser treatment due to severe bladder/urethral pain.

• Brand Name: DEKA SMARTXIDE2 LASER
• Type of Device: DEKA SMARTXIDE2 LASER
• Manufacturer (Section D): EL. EN. ELECTRONIC ENGINEERING SPA; via baldanzese 17; calenzano 50041 ; IT 50041
• MDR Report Key: 6679280
• MDR Text Key: 78765163
• Report Number: 1222993-2017-00028
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

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 Catalogue Number: 105-7030-100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2017
• Distributor Facility Aware Date: 06/05/2017
• Date Report to Manufacturer: 06/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR