Cook G25295Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002252950), received between Mar 29, 2016 and Apr 26, 2022 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Break; Break

  AS REPORTED, A COOK® SINGLE-USE HOLMIUM LASER FIBER WAS ATTACHED TO THE LASER, BUT THE LASER DID NOT READ THE FIBER. AN ATTEMPT TO TIGHTEN THE FIBER FURTHER ONTO THE MACHINE WAS MADE AND IT WAS AT THIS POINT THAT THE RED HUB ON THE FIBER CONNECTOR BROKE OFF. THE FIBER WAS REMOVED FROM THE LASER AND A NEW FIBER WAS USED TO COMPLETE THE UNSPECIFIED PROCEDURE WITH NO INCIDENTS. UPON RETURN EVALUATION OF THE DEVICE, THE FIBER TIP WAS FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14206423 ↗
• MalfunctionApr 5, 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: Insufficient Information

  MAUDE report 11613865 ↗
• MalfunctionJun 10, 2020Break; Break

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138698 ↗
• MalfunctionJan 29, 2019Break; Break

  AS REPORTED, A PATIENT OF UNKNOWN AGE AND GENDER UNDERWENT A URETEROSCOPY FOR URETERAL STONES IN WHICH A COOK SINGLE-USE HOLMIUM LASER FIBER, G25294, WAS USED. THE FIRST FIBER THAT WAS USED BROKE NEAR THE TIP WHEN THE SCOPE WAS FLEXED. NOTHING BROKE OFF IN THE PATIENT. THE FIBER WAS REMOVED AND THE PHYSICIAN USED ANOTHER FIBER, G25295 LOT# 7364233. THE TIP OF THIS FIBER BROKE WHEN ATTEMPTED TO FIRE. THERE WAS NO DAMAGE TO THE SCOPE & NO HARM TO THE PATIENT. A THIRD FIBER WAS USED WITH NO FURTHER COMPLICATIONS. TWO REPORTS ARE BEING FILED TO CAPTURE EACH OF THE TWO ALLEGED FAILURES. THE FIRST FIBER BREAKAGE REPORT - MFR. REPORT # 1820334-2019-00286. THIS REPORT IS FOR THE SECOND FIBER BREAKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285049 ↗
• MalfunctionOct 15, 2018Break; Arcing; Break; Arcing

  IT WAS REPORTED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY , THE COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE AT THE ENTRANCE OF THE SCOPE. THE UROLOGY RESIDENT WAS HANDLING THE SCOPE AND THE FIBER BROKE AT THE ENTRANCE OF THE SCOPE AND SHOCKED THE RESIDENT AND LEFT A MARK ON HER WRIST. THE HOLMIUM LASER WAS SHUT OFF IMMEDIATELY AND THERE WAS NO HARM TO THE PATIENT NOR WAS THERE ANYTHING LEFT INSIDE THE PATIENT. EVERYTHING HAPPENED OUTSIDE THE PATIENT AT THE SCOPE BUT THE RESIDENT DID HAVE A MARK ON HER WRIST FROM WHERE THE FIBER BROKE AND TOUCHED HER WRIST. ADDITIONAL INFORMATION PROVIDED ON 03OCT2018. IT WAS REPORTED THAT THE RESIDENT RECEIVED A SMALL RED MARK ON HER WRIST AND ONE DAY LATER SHE SAID SHE WAS FINE. THE RESIDENT DID NOT RECEIVE MEDICAL TREATMENT DUE TO THIS ISSUE. AS REPORTED, THE RESIDENT WAS MANIPULATING THE URETEROSCOPE WHILE THE LASER FIBER WAS IN THE WORKING CHANNEL OF THE SCOPE. SHE TURNED HER WRIST TO MANIPULATE THE SCOPE AND WENT TOO FAR. AS THERE WAS NOT ENOUGH SLACK ON THE LASER FIBER, IT BROKE AND LEFT A MARK ON HER WRIST. THE LASER WAS SHUT OFF PROMPTLY. THE CASE WAS CONTINUED AND PERFORMED AS SCHEDULED. THERE WERE NO ADDITIONAL PROCEDURES REQUIRED AS A

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7964917 ↗
• MalfunctionAug 17, 2018Break; Break

  IT WAS REPORTED DURING A FLEXIBLE URS FOR STONE REMOVAL IN THE KIDNEY, THE COOK® SINGLE-USE HOLMIUM LASER FIBER TIP BROKE AT THE TIP AFTER INSERTING IT INTO THE FLEXIBLE ENDOSCOPE. AS FURTHER EXPLAINED, THE LASER FIBER WAS INSERTED THROUGH A COLOPLAST TUOHY-BORST-ADAPTER IN THE FLEXIBLE URS ENDOSCOPE. THE ENDOSCOPE WAS IN THE ACCESS SHEATH IN THE URINARY TRACT AND NOT DEFLECTED. THE LASER FIBER WAS ADVANCED THROUGH THE WHOLE ENDOSCOPE. PRIOR TO THE FIRST USE AND A FIRST DEFLECTION, THE TIP OF THE LASER FIBER BROKE AND FELL IN THE PYELON. THE BROKEN PIECE WAS REMOVED WITH FORCEPS. A SECOND LASER FIBER WAS USED TO DISINTEGRATE THE STONE. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794100 ↗
• MalfunctionAug 3, 2018Crack

  THE COMPLAINANT REPORTED THAT THE SINGLE-USE HOLMIUM LASER FIBER (QUANTITY 3) CRACKED IN TWO HALVES WHEN STARTING TO LASER THE STONE. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7746880 ↗
• MalfunctionJul 9, 2018Material Separation; Material Separation

  IT WAS REPORTED, EARLY IN A BLADDER STONE--CYSTOLITHOTOMY PROCEDURE, THE TIP OF THE COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE OFF. AS REPORTED, ALL PIECES WERE REMOVED FROM PATIENT. AS REPORTED THE DEVICE WAS STRIPPED DOWN AND CONTINUED TO BE USED, PROCEDURE COMPLETED SUCCESSFULLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7670421 ↗
• InjuryJun 21, 2018Material Separation; Material Separation

  IT WAS REPORTED DURING A FLEXIBLE URETERORENOSCOPY, A STONE IN THE KIDNEY WAS FRAGMENTED WITH THE LASER. DURING THE LASERING PROCESS THE TIP OF THE COOK SINGLE-USE HOLMIUM LASER FIBER BROKE. A SMALL PIECE OF ABOUT 5 MM WAS LEFT IN THE KIDNEY. THE MISSING PIECE WILL BE REMOVED IN A SECOND SESSION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. REQUEST WAS MADE FOR ADDITIONAL INFORMATION REGARDING; DESCRIPTION OF PROCEDURE IN DETAIL, OTHER DEVICES AND/OR MEDICATIONS UTILIZED DURING THE PROCEDURE, WHEN WAS BROKEN PIECE RETRIEVED, HOW WAS IT RETRIEVED, WHAT WAS PATIENT OUTCOME POST RETRIEVAL OF DEVICE, DID THE PATIENT'S HEALTH STATUS/ANATOMY CONTRIBUTE TO THE MALFUNCTION OF THE DEVICE, HOWEVER THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 7625861 ↗
• InjuryDec 18, 2017Break; Break

  THE USER FACILITY REPORTED DURING A URETEROSCOPY PROCEDURE, THE COOK® SINGLE-USE HOLMIUM LASER FIBER GLASS TIP BROKE WHERE THE BLUE SHEATH MEETS. THE PHYSICIAN ATTEMPTED TO USE A BASKET TO GRAB THE REMNANTS OF THE FIBER, BUT LOST THE REMAINING PART OF THE DEVICE CLOSE TO THE ACCESS SHEATH. THE PHYSICIAN THINKS THE REMNANTS OF THE FIBER EXITED THROUGH THE PATIENT'S SHEATH BUT WAS UNCERTAIN. THE PHYSICIAN PROCEEDED WITH ANOTHER DEVICE AND COMPLETED THE PROCEDURE. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7126843 ↗
• MalfunctionOct 13, 2017Break; Break

  THE USER FACILITY REPORTED THAT DURING INITIAL USE OF THE COOK® SINGLE-USE HOLMIUM LASER FIBER WITH A HOLMIUM HL-30B LASER MACHINE IN A UROLOGY PROCEDURE, THE LASER FIBER BROKE IN HALF. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS PRODUCT ISSUE. A NEW FIBER WAS PUT IN THE LASER AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6948255 ↗
• MalfunctionAug 29, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE AREA REPRESENTATIVE REPORTED THAT THE CUSTOMER CALLED TO REPORT THERE IS SOMETHING INSIDE OF THE SEALED PACKAGE CONTAINING A COOK® SINGLE-USE HOLMIUM LASER FIBER. THIS DEVICE REMAINS UNOPENED AND UNUSED. THERE WAS NO PATIENT CONTACT AND NO CONSEQUENCES OR IMPACT TO A PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6828883 ↗
• InjuryMay 2, 2017Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING URETEROSCOPY WITH LASER LITHOTRIPSY STONE EXTRACTION PROCEDURE ON A PATIENT BY USING COOK® SINGLE-USE HOLMIUM LASER FIBER. DURING THE PROCEDURE, THE GLASS TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN FLUSHED THE PATIENT WITH FLUIDS TO REMOVE THE LASER FIBER FRAGMENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A SECOND LASER FIBER FROM THE SAME LOT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6538210 ↗
• InjuryMar 29, 2016Material Separation; Material Separation

  DURING A URETEROSCOPY PROCEDURE, THE FIBER BROKE OFF INSIDE THE PATIENT. LASER SETTINGS WERE 12HZ AND 1000MJ. THE SEPARATED PORTION WAS RETRIEVED USING A STONE RETRIEVAL BASKET. NO ADVERSE AFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Code Available

  MAUDE report 5531272 ↗