Light 4V PCMS00319Recalls & reported problems
Quanta System SPA · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033945934149), received between Sep 24, 2022 and Sep 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Optical Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Optical Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2022Optical Problem; Optical Problem
LASER SYSTEM CAUSED TRIVIAL FACIAL BURNS THAT WILL PROBABLY HEAL.
Patient problems: Burn(s)
MAUDE report 15475336 ↗
Other Powered Laser Surgical Instrument devices
- Moxy 0010-2400Boston Scientific Corporation · Powered Laser Surgical Instrument4,572 reports
- SOLTIVE TFL-PLSGyrus ACMI, LLC · Powered laser surgical instrument6 recalls450 reports
- Flexiva TracTip M0068403960Boston Scientific Corporation · Powered laser surgical instrument562 reports
- Moses™ AC-10030100Lumenis Ltd. · Powered Laser Surgical Instrument532 reports
- Flexiva M0068403910Boston Scientific Corporation · Powered laser surgical instrument376 reports
- Visualase 9735542Medtronic Navigation, Inc. · Powered laser surgical instrument1 recall2 deaths311 reports
- SOLTIVE TFL-SLSGyrus ACMI, LLC · Powered laser surgical instrument6 recalls33 reports
- NeuroBlate® System 20980Monteris Medical Inc · Powered laser surgical instrument7 deaths296 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.