FullFire® Diffusing Tip Laser Probe 20414-000 (REF DTP-000-01)Recalls & reported problems
Monteris Medical Inc · 3.3mm Diffusing Tip Laser Probe · 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 00816589020823), received between Nov 13, 2017 and Nov 13, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Charred” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Charred1
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.
MalfunctionNov 13, 2017Charred; Charred
IT WAS REPORTED THAT AFTER TREATMENT WHEN THE PROBE WAS REMOVED, THE PROBE SHOWED SOME SIGNS OF CHARRING ON THE OUTSIDE OF THE PROBE TIP/WINDOW. THIS APPEARED TO BE CHARRED TISSUE OR MATERIAL AND THE PROBE DID NOT APPEAR DAMAGED INTERNALLY. IT WAS NOTED THAT THE SCRUB TECH PLACED BONE WAX ON THE BOLT TO HOLD THE BOLT TO THE DRIVER PRIOR TO BOLT PLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7026905 ↗
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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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