Optilite G48620Recalls & reported problems
Cook Incorporated · OptiLite Single Use Holmium Laser Fiber Use With Odyssey Holmium Laser Systems · 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 00827002486201), received between May 14, 2020 and May 14, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2020Fracture; Fracture
IT WAS REPORTED, DURING A UROLOGY PROCEDURE USING A OPTILITE SINGLE-USE HOLMIUM LASER FIBER, THE LASER FIBER STOPPED WORKING. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION. UPON FURTHER INVESTIGATION AND PHYSICAL EVALUATION OF THE RETURNED COMPLAINT DEVICE ON 30APR2020, IT WAS NOTED THAT THE LASER FIBER WAS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10058038 ↗
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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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