MAUDE Adverse Event Report: BIOS S.R.L. SPLENDOR X; FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG)

Model Number	SPLENDOR X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation bios results: based on the information received: the device a-5000002us: (b)(6) was installed in the facility on (b)(6) 2026 and it's under warranty.Lumenis service engineer visited the facility and tested this device.He advised as follows: "confirmed persistent anomaly 25 energy nd: yag resonator getting out of range while testing at fluence 30+.Performed live energy check calibration for nd: yag and alex.All errors have cleared.Routed cables and fiber properly.Informed customer that have the foot pedal removed from its protective cover is a hazard.Device is grounded and no static discharge was seen.Cleaned device.Confirmed water tank was full.Performed energy tip checks, all passed.Confirmed power outputs are within specification.Device is ready for use." bios has reviewed the data and advised as follows: "the reported technical issue cannot be a potential cause of serious injury if it reoccurs, because the anomaly 25 occurs as expected to avoid anomalous energy delivery granting safety.Normal operating range is expected energy +/- 20% according to cei en 60601-2-22."customer must perform the energy check.It is mandatory at each device startup.Moreover, during the treatment energy is continuously monitored." device malfunction wasn't the suspected cause of the adverse event.Incident form - recorded in doc folder; not available since never sent by customer clinical expert report that the rate of injury is not available since the customer didn't sent us even one incident form and no photo.Rc: not confirmed since the customer didn't sent us even one incident form and no photo.Since no essential information was received within period which is determined for reportability, bios is reporting this event to the fda in an 'abundance of caution'.Should additional significant information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Event or Problem Description
Bios received from the importer lumenis on adverse event report on a patient who sustained shock following treatment by spx device.Customer advised that a deep shock to the head was felt when customers hair brushed the fiber.However, since the customer didn't sent us even one incident form and no photo, we treat this case as a single issue in current complaint.

• Brand Name: SPLENDOR X
• Common Device Name: FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG)
• Manufacturer (Section D): BIOS S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer (Section G): BIOS S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer Contact: edoardo tronchet ; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• MDR Report Key: 24996556
• Report Number: 1720381-2026-00006
• Device Sequence Number: 9757232
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K243445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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
• Operator of Device: Other
• Device Model Number: SPLENDOR X
• Device Catalogue Number: GA-5000002US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown