FullFire® Diffusing Tip Laser Probe 20414-00 (REF DTP-001-01)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816589020809), received between Apr 10, 2018 and Apr 10, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING THE ABLATION PROCEDURE, THE PATIENT EXPERIENCED TUMOR SEEDING. IT WAS NOTED THAT THE SECOND FOCUS WAS ALONG THE TRAJECTORY OF THE FIRST PROBE. A BIOPSY WAS TAKEN DURING THE CASE, AND AFTER THE BIOPSY THE PHYSICIAN FOLLOWED WITH A DIFFUSION PROBE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Code Available
MAUDE report 7412840 ↗
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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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