Litho 100 PVMS00055Recalls & reported problems
Quanta System SPA · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Quanta Litho 100 is a laser system used for surgical procedures. The reports mostly describe the laser failing or not delivering expected output, so the equipment could not be used, plus some calibration and optical issues. There are 54 reports, with no deaths and no injuries. No recalls name this device, and no reports were filed in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 08033945938369), received between Mar 8, 2019 and Dec 1, 2022 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (18 reports).
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
- Therapeutic or Diagnostic Output Failure18
- Output Problem12
- Defective Component4
- Defective Device4
- Appropriate Device Problem Term/Code Not Available3
- Break3
- Calibration Problem3
- Electrical /Electronic Property Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Known Impact Or Consequence To Patient15
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15892244 ↗MalfunctionNov 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15860270 ↗MalfunctionNov 4, 2022Mechanical Problem; Mechanical Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15726795 ↗MalfunctionSep 23, 2022Failure to Deliver Energy; Failure to Align; Calibration Problem; Failure to Deliver Energy; Failure to Align; Calibration Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15474977 ↗MalfunctionSep 16, 2022Break; Break
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15436580 ↗MalfunctionSep 16, 2022Break; Break
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15436576 ↗MalfunctionSep 1, 2022Defective Component; Defective Component
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334931 ↗MalfunctionAug 19, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15256897 ↗MalfunctionAug 19, 2022Excessive Heating; Excessive Heating
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15256866 ↗MalfunctionAug 9, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15189937 ↗MalfunctionJul 20, 2022Energy Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15064817 ↗MalfunctionJun 14, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14684280 ↗MalfunctionJun 7, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14615967 ↗MalfunctionApr 26, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14203828 ↗MalfunctionApr 14, 2022Defective Device
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14110403 ↗MalfunctionApr 7, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14039693 ↗MalfunctionApr 7, 2022Defective Device
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14039692 ↗MalfunctionMar 30, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13947475 ↗MalfunctionMar 25, 2022Defective Device
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13898008 ↗MalfunctionMar 25, 2022Defective Device
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13897995 ↗MalfunctionFeb 16, 2022Output Problem; Output Problem
THE LASER DEVICE HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13542932 ↗MalfunctionJan 17, 2022Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13264570 ↗MalfunctionSep 22, 2021Optical Problem; Output Problem; Optical Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12513289 ↗MalfunctionSep 9, 2021Output Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12444931 ↗MalfunctionAug 29, 2021Calibration Problem; Optical Problem; Output Problem; Calibration Problem; Optical Problem; Output Problem
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12381411 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page