Cook G25294Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00827002252943), received between Jun 1, 2016 and Jun 27, 2023 — classified as 7 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2023Material 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 17209789 ↗
• MalfunctionMar 8, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED 10MAR2023. THE CUSTOMER NO LONGER HAS THE FIBER TO RETURN.

  Patient problems: Insufficient Information

  MAUDE report 16507327 ↗
• MalfunctionFeb 9, 2023Break; Break

  AS REPORTED, DURING A URETEROSCOPY AND LASER LITHOTRIPSY, THE GLASS PORTION FROM A COOK® SINGLE-USE HOLMIUM LASER FIBER WAS BREAKING OFF AND SPLITTING. THE FAILURE HAPPENED AFTER THE LASER WAS FIRED 3 TO 5 TIMES AND IT WAS NOTICED ON THE SCREEN. ANOTHER DEVICE OF THE SAME TYPE WITH THE SAME LOT NUMBER WAS USED AND FAILED THE SAME WAY. THE PROCEDURE WAS NOT COMPLETED AND THE FACILITY IS HAVING THE PATIENT RETURN AT A LATER DATE NOT YET RESCHEDULED. THEY DID NOT WITNESS DIMINISHED OUTPUT OF THE LASER. THEIR STANDARD SETTINGS WERE .8 AND 8. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY AND DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16344585 ↗
• InjuryJul 22, 2022Break; Break

  THE USER FACILITY MEDWATCH REPORT # MW5110034 WAS RECEIVED AND THE REPORT SHOWED THAT THE CUSTOMER REPORTED: DURING A URETEROSCOPY WITH LASER LITHOTRIPSY FOR LEFT UROLITHIASIS, A 2 MM PIECE OF A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE DURING PROCEDURE AND COULD NOT BE RETRIEVED FROM THE PATIENT'S KIDNEY. ATTEMPTS TO FIND THE PIECE WERE ABANDONED, AS THE RISKS OF CONTINUING TO SEARCH FOR IT DID NOT OUTWEIGH THE BENEFITS. THERE IS LOW RISK TO THE PATIENT ESPECIALLY SINCE THE PIECE OF FIBER MAY WASH OUT ON ITS OWN. A CLINICAL DISCLOSURE WAS DONE WITH THE PATIENT AND HIS FAMILY, AND THIS WAS DOCUMENTED IN THE OPERATIVE REPORT. THE PATIENT WILL HAVE FOLLOW-UP WHICH INCLUDES A COMPUTED TOMOGRAPHY (CT) SCAN AT ABOUT 4 WEEKS POST REMOVAL OF THE URETERAL STENT THAT WAS PLACED DURING THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15086315 ↗
• MalfunctionMay 19, 2022Break; Break

  AS REPORTED, DURING A URETEROSCOPY, A PORTION OF THE GLASS TIP A COOK® SINGLE-USE HOLMIUM LASER FIBER PEELED, BUT DID NOT BREAK. A PICTURE OF THE DEVICE WAS PROVIDED WHICH SHOWS THE FIBER BROKE NEAR THE TIP. A NEW LASER FIBER WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES. 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 14438137 ↗
• MalfunctionMay 10, 2022Break; Break

  AS REPORTED, DURING A URETEROSCOPY, A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE NEAR THE CONJUNCTION OF THE FIBER TIP AND BLUE CLADDING. A NEW LASER FIBER WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347504 ↗
• MalfunctionApr 22, 2022Crack; Crack

  AS REPORTED, WHEN CONNECTING A COOK® SINGLE-USE HOLMIUM LASER FIBER TO A LASER MACHINE, THE FIBER COULD NOT BE RECOGNIZED BY THE LASER MACHINE, WHICH DISPLAYED AN ERROR MESSAGE READING, "NO FIBER ATTACHED". A SECOND LASER FIBER WAS USED TO CONTINUE THE PROCEDURE. UPON RETURN EVALUATION OF THE DEVICE, THE CLEAR FIBER TIP APPEARED TO HAVE A FEW CRACKS ON ITS SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190254 ↗
• MalfunctionFeb 8, 2022Break; Break

  AS REPORTED, DURING RETROGRADE INTRARENAL SURGERY (RIRS), A COOK® SINGLE-USE HOLMIUM LASER FIBER WAS FOUND BROKEN IN THE PACKAGE BEFORE OPENING IT. APPROXIMATELY 55 CM WAS BROKEN. A NEW FIBER WAS OPENED TO COMPLETE THE PROCEDURE. NO DAMAGE TO THE PACKAGING WAS NOTICED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13479646 ↗
• InjuryJan 31, 2022Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13402200 ↗
• MalfunctionJan 18, 2022Break; Break

  AS REPORTED, PRIOR TO A RETROGRADE INTRARENAL SURGERY (RIRS) IN THE KIDNEY, A COOK SINGLE-USE HOLMIUM LASER FIBER WAS NOTED TO BE BROKEN INSIDE OF THE PACKAGE. THE DEVICE WAS OPENED, AND IT WAS CONFIRMED TO BE BROKEN. A NEW LASER FIBER WAS OPENED AND USED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282837 ↗
• MalfunctionDec 14, 2021Break; Optical Problem; Break; Optical Problem

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001430 ↗
• InjuryDec 8, 2021Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12959973 ↗
• MalfunctionFeb 18, 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; No Consequences Or Impact To Patient

  MAUDE report 11345177 ↗
• MalfunctionFeb 24, 2020Break; Break

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9744863 ↗
• MalfunctionDec 11, 2019Fracture; Fracture

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 11DEC2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9451723 ↗
• MalfunctionDec 10, 2019Break; Break

  IT WAS REPORTED, PRIOR TO A URETEROSCOPY AND LASERTRIPSY USING A COOK SINGLE-USE HOLMIUM LASER FIBER, THE FIBER WIRE DETACHED FROM THE RED CONNECTING HUB. THE CASE WAS COMPLETED BY USING A NEW SAME TYPE OF FIBER. IT WAS ALSO INITIALLY REPORTED THAT THEY WERE JUST ABOUT THE USE THE LASER MACHINE BUT WHEN THEY OPENED THE PACK THE DEVICE WAS BROKEN. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444253 ↗
• MalfunctionNov 5, 2019Fracture; Fracture

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED ON 05NOV2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280233 ↗
• MalfunctionOct 28, 2019Break; Break

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 28OCT2019.

  Patient problems: No Patient Involvement

  MAUDE report 9243673 ↗
• MalfunctionOct 15, 2019Break; Break

  IT WAS ORIGINALLY REPORTED THAT THE PLUG-IN OF A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE OFF IN A LASER SYSTEM. THEY WERE ABLE TO REMOVE THE PLUG WITH NEEDLE NOSE PLIERS. WHEN THE DEVICE WAS RETURNED IT WAS DISCOVERED THAT THE FIBER WAS SEPARATED INTO SEVERAL PIECES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9194464 ↗
• MalfunctionSep 9, 2019Break; Break

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6) 2019.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8974220 ↗
• MalfunctionMay 16, 2019Fracture; Fracture

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616667 ↗
• MalfunctionMay 9, 2019Break; Break

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597347 ↗
• MalfunctionFeb 20, 2019Break; Break

  IT WAS REPORTED THAT DURING A CASE THEY HEARD A POPPING SOUND WHILE FIRING THE LASER. AFTER IN DEPTH TROUBLESHOOTING IT WAS FOUND THAT THE 273 FIBER IN USE DURING THE CASE HAD FAILED IN THE HUB. AS REPORTED, THE PROTRUDING METAL END HAD A SIGNIFICANT AMOUNT OF PLAY IN IT AND ALSO NO LIGHT WOULD PASS THROUGH THE FIBER ITSELF. NO PROBLEMS WERE FOUND WITH THE LASER MACHINE. ADDITIONAL PATIENT, EVENT AND DEVICE DETAILS HAVE BEEN REQUESTED. AT THE TIME OF THIS REPORT, THERE IS NO ADDITIONAL INFORMATION TO PROVIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8354002 ↗
• MalfunctionJan 29, 2019Break; Break

  ADDITIONAL INFORMATION: THE DIFFICULTY WITH THE DEVICES DELAYED THE CASE BY 1-2 MINUTES. THE DEVICES ARE NOT AVAILABLE FOR PHYSICAL EVALUATION. "THE CUSTOMER WAS NOT CONCERNED ABOUT THE FIBERS BREAKING AND THOUGHT THEY MAY HAVE BEEN HANDLED IMPROPERLY". THE FIBER WAS DISCARDED. THE FIBERS WERE BEING USED IN CONJUNCTION WITH A VERSAPULSE POWERSUITE 100W LASER (S/N (B)(4). THE POWER SETTINGS WERE : ENERGY/PULSE (J/P)-0.4, REPETITION RATE (HZ)-30, TOTAL ENERGY (WATTAGE) 12 WATTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284971 ↗
• MalfunctionDec 21, 2018Break; Break

  THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188865 ↗