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

Model Number M115A1

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Necrosis (1971); Scar Tissue (2060)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

The actual device involved in the event has been evaluated by authorized local service.The device was found correctly working within the specifications ((b)(4) service report performed in date may the 22nd, 2019).All the relevant data gathered during the investigation have been evaluated by of our product manager for the dermatologic area, (which is also a person qualified to perform a medical judgement as per 21 cfr part 803.20(c)(2)) with the following outcome: the event has been caused by the use of too much aggressive parameters related to the patient's condition.In fact the product manager evaluated the vascular lesions of the patient as a large blue veins and not red teleangiectasia (spider veins).This error is supported by the fact that the physician have used the parameters that are reported in the motus ay's clinical manual code 055-0182-20-021 rev 1.0, at chapter §3.3.6.1 "standard laser handpieces protocol" for vascular lesions.Based on that is possible to conclude that the physician have used the wrong settings relative to the patient's condition.Moreover, based on the pictures available of the patient, the area was highly vascularized (high density of veins in the area) which have caused a very intense laser absorption.The evaluation of our product manager also stated that the patient was in a condition at the limit for laser treatment and more suitable for sclerotherapy (very large veins).The investigation carried out did not conclude that a design deficiency or device malfunction was responsible for causing the event.Rather, it is possible to conclude, based on the above mentioned investigation, that there was a human factors issue, where a failure of the operator to appropriately set the device's parameters related to the intended treatment and patient's condition, contributed to the event.By manufacturer's investigation the operator's manual and risk analysis are adequate.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

In date may the 14th 2019, the (b)(4) distributor, (b)(4), sent a communication to el.En., relative to an adverse event in which the patient developed severe side effect, necrosis and scaring, on thigh and back of the knee following a vascular treatment with the motus ay nd:yag, ref m115a1, s/n (b)(4).The motus ay laser medical device is marketed in the us with 510(k) number k181486.The communication was supported with images of the treated area.The site ("(b)(6)) provided the following additional information: the physician treated the patient, of which no details have been reported beyond the skin type that is type-ii (fitzpatrick scale), in the left leg, thigh and back of the knee, for spider veins with motus ay laser medical device.Before the treatment the skin test was performed and during the treatment the zimmer cooler was used.In order to treat the injuries, the patient received the following medications: fucicort cream, bepanthen plus cream, ialugen plus cream, dermatix gel.Currently, the skin in the treated area is still very damaged presenting visible red scars due to skin necrosis the physician stated to have used the following parameters for the treatment: pulse duration: 1st pulse 5 ms, 2nd pulse 15 ms; spot size: 5mm; fluence: 105-110 j/cm2; frequency: 0.3hz.We, the manufacturer of device, became aware of the event on may 14th, 2019 by email from the (b)(4) distributor and, according to 21 cfr part 803 evaluated the event reportable because the patient received medical attention following the laser procedure.

• Brand Name: DEKA MOTUS AY
• Type of Device: DEKA MOTUS AY
• Manufacturer (Section D): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese 17; calenzano, 50041 ; IT 50041
• Manufacturer (Section G): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese 17; calenzano, 50041 ; IT 50041
• Manufacturer Contact: andrea checchi ; via baldanzese 17; calenzano, 50041 ; IT 50041
• MDR Report Key: 8686183
• MDR Text Key: 147596370
• Report Number: 3001431138-2019-00006
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K181486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M115A1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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