FDA Adverse Event Injury Summary report: N

SPLENDOR X

MDR report key: 17850033 · Received October 2, 2023

Report

Report Number
1720381-2023-00003
Event Type
Injury
Date Received
October 2, 2023
Manufacturer
BIOS S.R.L.
Product Code
GEX
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

BIOS, THROUGH LUMENIS, RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X DEVICE. IN THE DOCTOR'S OPINION, THE STRUCTURE OF THIS MENU DOES NOT CORRESPOND TO THE LOGIC OF WORKING WITH BLOOD VESSELS. WITH THIS PATIENT, HE TRIED WORKING WITH DIFFERENT PRESET MODES. ALMOST EVERYWHERE THERE IS A LONGER PULSE (MORE THAN 10 MILLISECONDS) AND THIS MODE BURNS. IF HE WERE MAKING A MENU FOR THE DEVICE, HE WOULD SIMPLY BE BASED ON THE DIAMETER OF THE VESSELS, FOR EXAMPLE. OR THEN TAKE ALL THE MOST COMMON NOSOLOGIES WITH LOCALIZATION (SINGLE CAPILLARY, MESH ON THE CHEEKS, SUPERFICIAL CAPILLARIES ON THE LEGS, PORT WINE, ROSACEA, VESSELS ON THE WING OF THE NOSE, SOMETHING LIKE THAT). DID NOT WORK 3MM, 150J, 15MS. 5MM. 50J, 20MS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1976694 SPLENDOR X Powered laser surgical instrument GEX

Patients

Seq Age Sex Outcome Treatment
1 Unknown