Cook G23734Recalls & reported problems
Cook Incorporated · Holmium Laser Fiber Single Use For use with Rhapsody H-30 or Odyssey 30 Holmium Laser System · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002237346), received between Dec 8, 2021 and Mar 2, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2023Break; Break
AS REPORTED, DURING A LASER PROCEDURE, THE TIP OF A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE OFF WHILE BEING INSERTED INTO AN INSTRUMENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16469182 ↗InjuryJun 14, 2022Break; Break
AS REPORTED, DURING A LASER LITHOTRIPSY, THE TIP OF A COOK SINGLE-USE HOLMIUM LASER FIBER BROKE/SEPARATED WHEN INSERTED INTO AN UNSPECIFIED LASER RESECTOSCOPE. THE USER WAS UNABLE TO PASS THE FIBER THROUGH THE RESECTOSCOPE, AS THE "BUTTON" WAS GETTING STUCK. AFTER THE FIBER TIP BROKE OFF, BLADDER IRRIGATION WAS PASSED THROUGH THE DISTAL END OF THE RESECTOSCOPE, AND THE BROKEN TIP WAS NOT FOUND. THE USER CHECKED THE BLADDER FOR THE SEPARATED PORTION OF THE DEVICE, WHICH WAS UNABLE TO BE LOCATED. ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 14690405 ↗MalfunctionDec 8, 2021Break; Break
NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12962007 ↗
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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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