ProFlex LSU200PFRecalls & reported problems
Innovaquartz LLC · Class 2
Data updated Oct 13, 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 00816959020682), received between Jun 5, 2017 and Jun 5, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2017Break; Detachment Of Device Component
IT WAS REPORTED THAT 4CM OF THE FIBER BROKE OFF, WHILE INSIDE THE PATIENT. THE COMPLAINANT ALLEGED THAT THE FIBER WAS LODGED BETWEEN PIECES OF THE STONE, AND WAS COMPLETELY REMOVED. THE FIBER WAS IN USE FOR FIVE MINUTES BEFORE THE BREAK OCCURRED. THERE WERE NO PROCEDURE DELAYS, NO ADDITIONAL PROCEDURES PERFORMED, AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6613059 ↗
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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 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.
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