ProFlex™ Single Use 200 Laser Lithotripsy FiberRecalls & reported problems
Innovaquartz LLC · Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00816959020521), received between Apr 9, 2026 and Apr 9, 2026 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026
DURING A UROLOGY SURGICAL PROCEDURE USING A LASER FIBER AND MACHINE SUPPLIED BY ROCKY TOP LITHO, A LASER WIRE BURST IN THE PROVIDER'S HANDS AND HAD TO BE REMOVED FROM THE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24828606 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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