Cook G25293Recalls & reported problems
Cook Incorporated · Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems · Class 2
Quick summary
This Cook single-use holmium laser fiber is used with laser systems to break up stones during procedures such as ureteroscopy. The 66 reports mostly describe the fiber breaking, splitting, or separating, sometimes before use and sometimes partway through a procedure; most involved no harm to the patient and no piece left inside the body, while 2 reports mention an injury, with no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00827002252936), received between May 2, 2017 and Jun 9, 2025 — classified as 2 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Break” (44 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
- Break44
- Fracture5
- Material Separation4
- Device Operates Differently Than Expected3
- Crack2
- Device Damaged Prior to Use2
- Energy Output Problem2
- Sparking2
Patient problems
- No Consequences Or Impact To Patient30
- No Clinical Signs, Symptoms or Conditions25
- No Known Impact Or Consequence To Patient8
- Insufficient Information4
- Device Embedded In Tissue or Plaque3
- No Patient Involvement2
- Burn(s)1
- No Information1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2025Break; Break
IT WAS REPORTED A COOK® SINGLE-USE HOLMIUM LASER FIBER WAS FOUND TO BE BROKEN, DURING AN UNSPECIFIED PROCEDURE. THE ISSUE WAS FOUND AT THE START OF THE PROCEDURE WHEN THE FIBER WAS CONNECTED TO THE LASER MACHINE. THE RAY OF GREEN LIGHT LEAKED OUT OF THE FIBER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22165957 ↗MalfunctionOct 24, 2024Break; Break
AS REPORTED, DURING AN URETEROSCOPY PROCEDURE, AFTER 15 MINUTES OF USE, THE COOK® SINGLE-USE HOLMIUM LASER FIBER SPLIT IN TWO, ABOUT 110 CM FROM THE CONNECTOR. THE USE OF THE FIBER WAS DISCONTINUED. THE OR ASSISTANT WAS SLIGHTLY BURNED ON A HAND. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: Burn(s)
MAUDE report 20523747 ↗MalfunctionMay 21, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED 28MAY2024: AS REPORTED, THE PROCEDURE BEING PERFORMED WAS A URETEROSCOPY (URS). THE FIBER WAS INSPECTED FOR DAMAGE PRIOR TO USE. THE LASER LIGHT WAS VISIBLE THROUGH THE FIBER BEFORE THE AIMING BEAM WAS CHECKED. THE STONE WAS CLEARED SUCCESSFULLY. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT OR STAFF.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19361624 ↗MalfunctionJan 23, 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 18564220 ↗MalfunctionAug 3, 2023Break; Break
UPON EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2023 A COOK® SINGLE-USE HOLMIUM LASER FIBER WAS RETURNED IN TWO PIECES. IT WAS ORIGINALLY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE AFTER A FEW MINUTES OF USE OF THE "FIBER BROKE DOWN". THE USER LOST TIME AND THE FIBER WAS REPLACED WITH A NEW ONE FROM THE SAME LOT. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17453437 ↗MalfunctionMar 27, 2023Break; 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 16622487 ↗MalfunctionFeb 20, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 16405863 ↗MalfunctionFeb 20, 2023Break; 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 16405862 ↗MalfunctionSep 29, 2022Break; 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 15507158 ↗MalfunctionJun 16, 2022Break; Break
AS REPORTED, THE PATIENT HAD A VERY LARGE, ALMOST 2CM, STONE AND WAS UNDERGOING A URETEROSCOPY. TWO FIBERS CAME INTO CONTACT WITH THE URETHRAL STONES DURING THE PROCEDURE. THE COOK LASER WAS SET AT 0.5 J/20 HZ AND STERILE WATER WAS USED DURING THE PROCEDURE. THE PHYSICIAN WAS INSIDE OF THE PATIENT LASERING THE STONE WHEN THE FIRST FIBER (B)(4) WAS NOTED TO BE FRAYED AT THE TIP AFTER ABOUT 4.5 PULSES. THE FIBER WAS REPLACED WITH ANOTHER SAME TYPE DEVICE. AFTER ABOUT 3 MORE PULSES, THE SECOND FIBER (B)(4) SNAPPED IN HALF ABOUT 12 INCHES FROM THE TIP. THE USER HEARD THE "POP" AND REMOVED THEIR FOOT FROM THE PEDAL TO STOP THE POWER. NO INJURIES TO STAFF OR PATIENT WERE NOTED DUE TO THIS OCCURRENCE. POWER WAS ACTIVELY BEING DELIVERED THROUGH THE LASER WHEN THE FIBER BROKE. THE PIECE THAT BROKE WAS OUTSIDE OF THE PATIENT'S BODY, AND THE PHYSICIAN WAS ABLE TO MANUALLY REMOVE THE REST OF THE FIBER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A SIZE 273 FIBER. THERE WAS NO DAMAGE NOTED TO EITHER FIBER PRIOR TO THE PROCEDURE. NO PIECES OF THE FIBERS WERE RETAINED INSIDE OF THE PATIENT. NO ADDITIONAL PROCEDURES OR UNEXPECTED COMPLICATIONS OCCURRED DUE TO THE BROKEN FIBERS THAT WE HAVE B
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14711756 ↗MalfunctionJun 16, 2022Material Frayed; Material Frayed
AS REPORTED, THE PATIENT HAD A VERY LARGE, ALMOST 2CM, STONE AND WAS UNDERGOING A URETEROSCOPY. TWO FIBERS CAME INTO CONTACT WITH THE URETHRAL STONES DURING THE PROCEDURE. THE COOK LASER WAS SET AT 0.5 J/20 HZ AND STERILE WATER WAS USED DURING THE PROCEDURE. THE PHYSICIAN WAS INSIDE OF THE PATIENT LASERING THE STONE WHEN THE FIRST FIBER (PR365306) WAS NOTED TO BE FRAYED AT THE TIP AFTER ABOUT 4.5 PULSES. THE FIBER WAS REPLACED WITH ANOTHER SAME TYPE DEVICE. AFTER ABOUT 3 MORE PULSES, THE SECOND FIBER (PR 365312) SNAPPED IN HALF ABOUT 12 INCHES FROM THE TIP. THE USER HEARD THE "POP" AND REMOVED THEIR FOOT FROM THE PEDAL TO STOP THE POWER. NO INJURIES TO STAFF OR PATIENT WERE NOTED DUE TO THIS OCCURRENCE. POWER WAS ACTIVELY BEING DELIVERED THROUGH THE LASER WHEN THE FIBER BROKE. THE PIECE THAT BROKE WAS OUTSIDE OF THE PATIENT'S BODY, AND THE PHYSICIAN WAS ABLE TO MANUALLY REMOVE THE REST OF THE FIBER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A SIZE 273 FIBER. THERE WAS NO DAMAGE NOTED TO EITHER FIBER PRIOR TO THE PROCEDURE. NO PIECES OF THE FIBERS WERE RETAINED INSIDE OF THE PATIENT. NO ADDITIONAL PROCEDURES OR UNEXPECTED COMPLICATIONS OCCURRED DUE TO THE BROKEN FIBERS THAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14711720 ↗MalfunctionMar 24, 2022Break; Break
AS REPORTED, A COOK® SINGLE-USE HOLMIUM LASER FIBER WAS IN THE PATIENT¿S URINARY SYSTEM WHEN THE PHYSICIAN DISCOVERED THAT THE PILOT LIGHT DID NOT ILLUMINATE AT THE END OF THE FIBER. THE PHYSICIAN FIRED A COUPLE TEST SHOTS. THE ENERGY DID NOT COME OUT FROM THE FIBER TIP AS IT SHOULD, BUT OUT OF A SECTION OF THE FIBER WHICH WAS OUTSIDE THE PATIENT, UNDER A WET TOWEL, USED TO PROTECT THE FIBER AND KEEP IT IN PLACE. THE FIBER BURNED A HOLE THROUGH THE TOWEL AND PATIENT¿S LEG COMPRESSIONS, BUT DID NOT MAKE CONTACT WITH THE PATIENT. A NEW LASER FIBER OF THE SAME REFERENCE NUMBER WAS USED WITH NO ISSUE TO COMPLETE THE UNSPECIFIED PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13893136 ↗MalfunctionMar 19, 2022Break; Break
AS REPORTED, A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE. THE AIMING BEAM WAS NOT VISIBLE. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13824304 ↗MalfunctionFeb 21, 2022Break; Break
AS REPORTED, A COOK SINGLE-USE HOLMIUM LASER FIBER WAS BROKEN IN THE MIDDLE OF DEVICE DURING AN UNSPECIFIED PROCEDURE. THE DEVICE WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS OCCURRENCE. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13568047 ↗MalfunctionFeb 18, 2022Break; Break
AS REPORTED, A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE "IN THE MIDDLE WHEN OPENING." A NEW FIBER WAS USED AND NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13559023 ↗MalfunctionJan 21, 2022Break; Break
AS REPORTED, DURING A URETEROSCOPY (URS), A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE AFTER TWO MINUTES OF USE. THE GREEN LIGHT (AIMING BEAM) STOPPED ILLUMINATING AND THE FIBER BECAME UNUSABLE. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13313957 ↗MalfunctionDec 14, 2021Break; Break
IT WAS INITIALLY REPORTED THAT A COOK® SINGLE-USE HOLMIUM LASER FIBER WAS UNABLE TO BE DETECTED BY THE LASER UNIT DURING A URETEROSCOPY PROCEDURE. PHYSICIAN USED ANOTHER LASER FIBER TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE UPON DEVICE RETURN AND INVESTIGATION ON 30-NOV-2021, IT WAS NOTED THAT THE LASER FIBER WAS DISCONNECTED AT THE HUB, AND THERE WAS CHARRING NOTED ON THE PROXIMAL END OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13006901 ↗MalfunctionDec 14, 2021Break; 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 13005843 ↗MalfunctionNov 4, 2021Break; Break
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12750650 ↗MalfunctionAug 26, 2021Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED ON 20OCT2021: THE METAL END OF THE FIBER "SNAPPED" WHILE ATTEMPTING TO DISCONNECT FROM THE MACHINE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12369753 ↗MalfunctionAug 17, 2021Sparking; Sparking
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12332375 ↗MalfunctionJun 21, 2021Break; Break
NO NEW PATIENT OR PROCEDURE INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12032424 ↗MalfunctionJun 17, 2021Break; 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 12019852 ↗MalfunctionApr 26, 2021Break; Break
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11723147 ↗MalfunctionApr 23, 2021Material Separation; Material Separation
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 11715513 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.