MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-01-25 for CYNOSURE CELLULAZE - SLT II M094E1 manufactured by El.en. Electronic Engineering S.p.a..
[36747995]
(b)(4). Cynosure service technician evaluated the device for calibration and performance of laser and accessories. The cellulaze-slt ii unit and relevant accessories were determined to be operating properly within their specifications. No failure detected (cynosure's service (b)(4)). Treatment parameters used by physician were within clinical guidelines. Since this event took place about one year ago on (b)(6) 2014, the authorized service verified that there is no pending issue with the slt ii device. It was last checked in (b)(6) 2015 without any problems since then (cynosure service report is (b)(4) dated (b)(6) 2015). Moreover, since the last service visit, the unit is correctly working without any pending issue. Because of this, there was no further service report created. Currently, no additional service visit or device returning is required for 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 human factors issue, where a failure to appropriately use the device, contributed to event. Scarring and skin and fat tissue necrosis are expected adverse effects from laser treatments to the anatomic district of the laser procedure as reported by slt ii operator manual code om094e1_g. V05 (revision valid at the date of event) at section 9 "clinica l applications - adverse effects". The same anticipated adverse effects are also reported in the clinical reference guide (code 921-7014-001), provided by cynosure together with the device, at chapter 2 "clinical application - adverse effects". Moreover, the operator's manual specifies (section 1 - "introduction") that this device is intended for the use by a licensed practitioner with experience in the field of liposuction and lipolysis treatments. No failure detected on the actual device evaluated. Device working within specs. No remedial actions required. Manufacturer's investigation on this event confirms the result of the previous incident involving the same device unit at the same clinic, happened on (b)(6) 2012, managed with el. En. 's mdr report # 3001431138-2016-00001. This initial report is to be considered as final report, unless fda has further questions.
Patient Sequence No: 1, Text Type: N, H10
[36747996]
(b)(4). A female patient ((b)(6) at the time of the event) suffered a burn on the abdomen region which resulted in scarring from a laser-assisted liposuction procedure with the device. Patient was prescribed medication for preventive case use: triazolom, phenergan, and keflex and was monitored by site doctor on multiple follow up appointments. No other information was made available by the customer site regarding treatment parameters/details of the event. The patient is now doing well, but this incident was classified as a reportable event by the us importer because patient received medical intervention and developed scarring. The us importer, (b)(4) report to fda for this event (# 1222993-2016-00001) on (b)(4). This adverse event actually occurred on (b)(6) 2014, more that one year ago, but us importer became aware of this incident on (b)(6) 2015 after patient had recently gone to a news crew/press "press/news crew" to share experience about the customer site. This event represent a second incident involving the same device unit (serial number (b)(4)) at the same customer site (laser aesthetics body and wellness" - (b)(4) us) and with similar injury suffered by a different patient. Previous event occurred about two years and half before the first one (event date (b)(6) 2012) as referenced in the el. En. 's mdr report # 3001431138-2016-00001 (and corresponding us importer mdr report # 1222993-2015-00058). We, the manufacturer of device, became aware of the event on (b)(6) 2016 by email from the us importer and, according to 21 cfr part 803. 50(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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001431138-2016-00002 |
| MDR Report Key | 5387636 |
| Report Source | OTHER |
| Date Received | 2016-01-25 |
| Date of Report | 2016-01-25 |
| Date of Event | 2014-12-22 |
| Date Mfgr Received | 2015-12-28 |
| Device Manufacturer Date | 2008-09-19 |
| Date Added to Maude | 2016-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANDREA CHECCHI |
| Manufacturer Street | VIA BALDANZESE 17 |
| Manufacturer City | CALENZANO, FIRENZE 50041 |
| Manufacturer Country | IT |
| Manufacturer Postal | 50041 |
| Manufacturer Phone | 0558826807 |
| Manufacturer G1 | EL.EN. ELECTRONIC ENGINEERING S.P.A. |
| Manufacturer Street | VIA BALDANZESE 17 |
| Manufacturer City | CALENZANO, FIRENZE 50041 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 50041 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYNOSURE CELLULAZE - SLT II |
| Generic Name | ND: YAG LASER |
| Product Code | OYW |
| Date Received | 2016-01-25 |
| Model Number | M094E1 |
| Catalog Number | M094E1 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EL.EN. ELECTRONIC ENGINEERING S.P.A. |
| Manufacturer Address | VIA BALDANZESE 17 CALENZANO, FIRENZE 50041 IT 50041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-01-25 |