Olympus Empower H100 EMP-H100Recalls & reported problems
Quanta System SPA · Distributed by Gyrus ACMI, L.P. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Empower H100 is a powered laser surgical instrument used during operations. The 56 reports mostly describe the laser stopping or failing to deliver output mid-procedure, sometimes with leaking fluid, which in one case postponed surgery. No recalls name this device, and reports are flat: none in the last 12 months or the 12 months before.
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
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 08059173390052), received between Jan 17, 2020 and Mar 21, 2024 — classified as 56 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. 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
- Therapeutic or Diagnostic Output Failure18
- Output Problem14
- Appropriate Device Problem Term/Code Not Available7
- Fluid/Blood Leak5
- Electrical /Electronic Property Problem3
- Calibration Problem2
- Defective Device2
- Energy Output Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Known Impact Or Consequence To Patient10
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DEVICE STOPPED WORKING IN THE MIDDLE OF SURGICAL PROCEDURE WITH PATIENT UNDER ANAESTHESIA WITH CONSEQUENT TREATMENT POSTPONEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18947912 ↗MalfunctionOct 21, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property 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 15649158 ↗MalfunctionJul 13, 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 14998175 ↗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 14684245 ↗MalfunctionMay 27, 2022Energy Output Problem; Energy 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 14521018 ↗MalfunctionMay 27, 2022Defective Device
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 14521015 ↗MalfunctionApr 5, 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 14014955 ↗MalfunctionMar 23, 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 13857110 ↗MalfunctionMar 8, 2022Therapeutic or Diagnostic Output Failure
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 13692316 ↗MalfunctionFeb 10, 2022Therapeutic or Diagnostic Output Failure
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 13505536 ↗MalfunctionFeb 4, 2022Energy Output Problem; Energy 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 13451386 ↗MalfunctionJan 14, 2022Therapeutic or Diagnostic Output Failure
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 13257145 ↗MalfunctionJan 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
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 13227590 ↗MalfunctionJan 5, 2022Fluid/Blood Leak; Fluid/Blood Leak
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 13167971 ↗MalfunctionDec 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
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 13024109 ↗MalfunctionNov 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
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 12877221 ↗MalfunctionSep 24, 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 12525379 ↗MalfunctionSep 24, 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 12524837 ↗MalfunctionSep 5, 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 12426510 ↗MalfunctionSep 1, 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 12406370 ↗MalfunctionAug 29, 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 12381412 ↗MalfunctionAug 12, 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 12311705 ↗MalfunctionAug 10, 2021Failure to Power Up; Failure to Power Up
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 12299237 ↗MalfunctionJul 22, 2021Complete Loss of Power; Complete Loss of Power
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 12213118 ↗MalfunctionJul 15, 2021Failure to Power Up; Failure to Power Up
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 12177912 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page