SMARTXIDE TETRA PRO M118G1Recalls & reported problems
Deka M.E.L.A. Srl · The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08034108512808), received between Feb 27, 2026 and Feb 27, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2026Improper or Incorrect Procedure or Method
IN DATE MARCH THE 3RD, 2026 THE US AGENT, (B)(6), MADE US AWARE OF A VOLUNTARY MEDWATCH REPORT THAT HAS BEEN RECEIVED FROM THE US FDA IN WHICH IT IS REPORTED OF AN ADVERSE EVENT FOLLOWING A SKIN RESURFACING TREATMENT WITH THE DEVICE SMARTXIDE TETRA PRO. THE CODE OF THE ABOVE MENTIONED MEDWATCH REPORT IS: MW5183277. IN THE JUST MENTIONED MW REPORT IT IS REPORTED THE FOLLOWING: THE CLINIC REPORTS OF AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED SWELLING ON THE FACE. THE SWELLING IS CAUSING THE PATIENT ISSUE WITH BLINKING. THE CLINIC REPORTED TO HAVE TREATED THE EYE WITHOUT ANY EYE SHIELD PROTECTION BUT TO HAVE LIMITED THE TREATMENT ON THE ORBITAL RIM AND TO HAVE PULLED UPPER AND LOWER LID SKIN AWAY FROM THE EYEBALL WHEN HE PULSED. IT IS ALSO REPORTED THAT THE PATIENT SEEK MEDICAL ATTENTION FROM AN OPHTHALMOLOGIST WHO DIAGNOSED CORNEAL INFLAMMATION AND PRESCRIBED HER WITH OINTMENT AND EYE TAPING DURING THE NIGHT. IF THE CONDITION WILL NOT IMPROVE, THE OPHTHALMOLOGIST SUGGESTED THE PATIENT TO PROCEED WITH A PUNCTUAL PLUG ON THE TEAR DUCT. THE CLINIC FOLLOWED UP ON THE PATIENT TO CHECK ON HER HEALING: THE PATIENT REPORTED TO HAVE NOT IMPROVED AND THAT SHE WILL BE UNDERGO THE PUNCTUAL PL
Patient problems: Swelling/ Edema
MAUDE report 24468449 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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