Cook G23666Recalls & reported problems
Cook Incorporated · Holmium Laser Fiber Multi Use For use with Rhapsody H-30 or Odyssey 30 Holmium Laser System · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002236667), received between Aug 3, 2018 and Oct 24, 2024 — classified as 4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Crack1
- Material Frayed1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2024Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20521720 ↗MalfunctionMar 29, 2021Crack; Crack
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11582958 ↗MalfunctionDec 7, 2018Break; Break
ADDITIONAL INFORMATION RECEIVED ON 27DEC2018: THE CUSTOMER REFURBISHES FIBERS AT THEIR FACILITY USING SOLUTION FOR FAST STERILIZATION. THE FIBER USED IN THIS EVENT HAD NOT BEEN STERILIZED; THE REPORTED ISSUE OCCURRED ON THE FIRST CASE. THE FIBER HAD BEEN USED ZERO TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8141230 ↗MalfunctionAug 3, 2018Break; Material Frayed; Stretched
THE COMPLAINANT REPORTED THAT THE MULTI-USE HOLMIUM LASER FIBER BROKE ON ITS FIRST USE. THE REPORTED TOTAL ENERGY USED WAS 9.6 JOULES. THIS ISSUE WAS NOTED AFTER THE URETEROSCOPY. IT WAS FURTHER NOTED THAT THE SHEATHING MATERIAL WAS STRETCHED AND FRAYED AT THE POINT OF SEPARATION. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7747355 ↗
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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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