MAUDE Adverse Event Report: BERGER AND KRAFT EPILME; ALIYA

Model Number	APE
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the report submitted by the distributor, the hand piece started firing by itself while in the holder and the touch screen display would not respond to touch.The sapphire tip is frosted over and the front cover is melted.The power meter inside the hand piece holder is damaged.Advised the clinic to not use the device and return for investigation by the manufacturer.This is an isolated occurrence and no other complaints of this nature have been reported.No injuries were associated with this event.Technical investigation determined that the incident was caused by a mechanical malfunction of the micro-switch used in the applicator trigger assembly.The micro-switch remained in an activated state after the operator released the hand trigger, resulting in continuous trigger signal detection by the system.As a consequence, the applicator continued emitting pulses unintentionally while positioned in the docking area.Inspection of the applicator indicated that the micro-switch in the trigger mechanism had likely become mechanically blocked or failed internally, preventing proper return of the micro-switch to its released position.The issue was reproduced during functional testing and confirmed during applicator inspection.The main device is functioning as intended.The issue is isolated to the handpiece only.A capa investigation has been opened to identify root cause and how to keep this event from reoccurring in the future.

• Brand Name: EPILME
• Common Device Name: ALIYA
• Manufacturer (Section D): BERGER AND KRAFT; slowikowski 85 street; raszyn, mazowieckie 05-09 0; PL 05-090
• MDR Report Key: 25161793
• Report Number: 3015433394-2026-00002
• Device Sequence Number: 16134756
• Product Code: GEX
• UDI-Device Identifier: 00850017374218
• UDI-Public: (01)00850017374218
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2026
• Report Date (Section F): 05/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: APE
• Device Catalogue Number: 300-1701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/13/2026
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 05/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/13/2026