MAUDE Adverse Event Report: ALMA LASERS LTD ACCENT XL; RF

Model Number UNIPOLAR , BIPOLAR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Please note that this is a resubmission of a previously submitted mdr on 05/22/2018.Acknowledgement 3 showed an error.The emdr helpdesk was contacted and the company was informed that there was a error and the mdr needs to be resubmitted.Multiple attempts were made by alma to retrieve the device.On last attempt for device retrieval, customer stated that the device has been working fine since the incident.The device manufacture date for device with serial (b)(4) and (b)(4) is 10/21/2015.This is being provided here due to software limitations of data entry in the respective field.An independent medical expert diagnosed the injury as a second degree burn that was most likely reversible.Based on the non-permanent nature of injury, this event was determined to be non-reportable.Subsequent follow-ups were performed by alma to request the patient outcome but the facility was not responsive.Therefore, alma concluded that given the uncertainty/inconclusive evidence pertaining to patient's skin condition even after 90 days, the event is to be reported in compliance with the company's protocol.The third follow-up (04/23/2018) is considered as the report date for this event.Based on available information, alma lasers clinical determined that overlapping-frequent passes on the same area may have caused excessive heating of the belly button area resulting in the localized burn/blister.A brief stationary exposure at those settings could also lead to this injury as the device is supposed to be used in motion.The most likely root cause is misuse.

Event Description

The suspected device was used on the patient with skin type iv on the abdomen for rf procedure.It was her second treatment session.Patient experienced a hot sensation during the procedure which was cooled off immediately by the facility.The facility physician diagnosed the alleged injury as "burn" and patient was given 1% hydrocortisone cream and zo revitatrol for medical care.

• Brand Name: ACCENT XL
• Type of Device: RF
• Manufacturer (Section D): ALMA LASERS LTD; 14 & 15 halamish st. pob 3021; caesarea north industrial park; caesarea hazafon 3088900, ; IS
• Manufacturer Contact: ariela albalak ; 14 & 15 halamish st. pob 3021; caesarea north industrial park; caesarea hazafon 3088900, ; IS
• MDR Report Key: 7648531
• MDR Text Key: 112703698
• Report Number: 3004167969-2018-00002
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNIPOLAR , BIPOLAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2018
• Device Age: 2 YR
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability