Cook G23553Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00827002235533), received between Aug 29, 2016 and May 5, 2026 — classified as 7 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Break” (36 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS FOUND TO BE "FOLDED ON ITSELF" WHEN THE PACKAGE WAS OPENED PRIOR TO A FLEXIBLE URETEROSCOPY + PYELOSCOPY/LASERTRIPSY FOR A KIDNEY STONE REMOVAL PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086565 ↗
• MalfunctionSep 26, 2025Break; Break

  AS REPORTED, DURING A LITHOTRIPSY PROCEDURE THE "ENTIRE TIP" OF A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE OFF INSIDE THE PATIENT'S BODY. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT'S BODY USING AN UNSPECIFIED STONE BASKET. THE PROCEDURE WAS COMPLETED WITH A SECOND UNSPECIFIED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23156720 ↗
• MalfunctionSep 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING A LITHOTRIPSY PROCEDURE, THE USER FOUND THAT A 'COOK SINGLE-USE HOLMIUM LASER FIBER' BROKE LEAVING "ONLY 1 INCH OF FIBER" LEFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING A NEW 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110437 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE COOK SINGLE-USE HOLMIUM LASER FIBER BROKE OFF. BEFORE THE PROCEDURE, NO ISSUES WERE NOTED WHEN THE LASER FIBER WAS REMOVED FROM THE PACKAGING AND INSPECTED. THEREFORE, THE FIBER WAS SCREWED WITHOUT ISSUE INTO THE LASER APERTURE AND TURNED ON. THE LASER BEAM MADE A PERFECT CIRCLE AND THE APERTURE WAS SWITCHED TO 'READY'. DURING THE PROCEDURE, THE LASER FIBER BROKE UP THE KIDNEY STONE 'WITHOUT ISSUE FOR QUITE A WHILE' BEFORE A STAFF PERSON NOTED THAT PART OF THE TIP OF THE FIBER HAD BROKEN OFF. THE FIBER WAS REMOVED, AND THE TIP OF THE FIBER WAS RECEIVED BY IRRIGATING THE KIDNEY AND BLADDER. THE REMAINING PARTS OF THE KIDNEY STONE WERE REMOVED WITH AN UNSPECIFIED STONE EXTRACTOR. NO PART OF THE TIP OF THE LASER FIBER REMAINED IN THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22863298 ↗
• MalfunctionNov 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  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 20694898 ↗
• MalfunctionSep 3, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, THE SCRUB NURSE NOTICED DURING AN UNSPECIFIED PROCEDURE, THE TIP OF THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS BENT, WHERE IT SHOULD HAVE REMAINED STRAIGHT. THE DEVICE WAS NOT CAUGHT ON ANYTHING PRIOR TO USE. BLUE FRAGMENTS WERE FOUND TO HAVE COME FROM THE FIBER AND FLOATING WITHIN THE BLADDER AREA. THE SURGEON CATHETERIZED THE PATIENT POST PROCEDURE TO FLUSH ANY FRAGMENTS THAT MAY HAVE REMAINED WITHIN THE PATIENT. NO PATIENT HARM HAS BEEN REPORTED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20127529 ↗
• MalfunctionMar 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 14MAY2024: THE ISSUE INVOLVING THE FIBER WAS FOUND AT THE END OF THE PROCEDURE. THE LASER FIBER WAS OPENED AND USED. AT THE CONCLUSION OF THE CASE AS THE FIBER WAS ATTEMPTED TO BE REMOVED IT WAS FOUND THE RUBBER CONNECTOR COVER HAD COME AWAY FROM THE METAL CONNECTOR THAT GOES INTO THE MACHINE, MAKING IT DIFFICULT TO REMOVE FROM THE MACHINE. BIO MED STAFF ASSISTED IN THE REMOVAL OF THE FIBER. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT BUT A DELAY IN THEATRE AS THE MACHINE WAS REQUIRED FOR FURTHER CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955639 ↗
• MalfunctionNov 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, PRIOR TO PATIENT CONTACT/USE, THE SHAFT OF A 'COOK SINGLE-USE HOLMIUM LASER FIBER' DETACHED FROM THE CONNECTOR AS IT WAS BEING CONNECTED TO THE LASER UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187923 ↗
• MalfunctionOct 3, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR-LIKE SUBSTANCE WAS DISCOVERED PRIOR TO USE INSIDE OF THE PACKAGING OF A COOK® SINGLE-USE HOLMIUM LASER FIBER. THE DEVICE WAS PULLED FOR A PROCEDURE BUT A HAIR-LIKE SUBSTANCE WAS NOTICED PRIOR TO OPENING. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862827 ↗
• MalfunctionSep 18, 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 17767588 ↗
• MalfunctionAug 28, 2023Break; Break

  IT WAS REPORTED THAT A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE IN THE MIDDLE OF THE SHAFT DURING A URETEROSCOPY AND LITHOTRIPSY PROCEDURE FOR AN UNKNOWN PATIENT. A NEW FIBER WAS OPENED TO COMPLETE THE PROCEDURE AS NORMAL WITHOUT ANY FURTHER ISSUES. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638128 ↗
• MalfunctionJul 28, 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 17416078 ↗
• MalfunctionJul 25, 2023Break; Break

  AS REPORTED, DURING A URETEROSCOPY (URS) USING A COOK® SINGLE-USE HOLMIUM LASER FIBER, THE USER HEARD A "LOUD BANG" AND FOUND THE FIBER WAS DISCONNECTED FROM THE CONNECTOR. A NEW FIBER WAS USED TO FINISH THE PROCEDURE WITHOUT ANY OTHER PROBLEMS. 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 17387956 ↗
• MalfunctionJun 7, 2023Break; Break

  AS REPORTED, DURING A LASER LITHOTRIPSY PROCEDURE, THE SHAFT OF THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS NOTED TO BE SEPARATED FROM THE RED CONNECTOR UPON REMOVAL FROM THE PACKAGING. A NEW LASER FIBER WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081467 ↗
• MalfunctionJan 19, 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 16207550 ↗
• MalfunctionNov 14, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  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 15794353 ↗
• MalfunctionOct 11, 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 15578992 ↗
• MalfunctionSep 8, 2022Break; Break

  AS REPORTED, DURING AN UNSPECIFIED LASER PROCEDURE, A COOK® SINGLE-USE HOLMIUM LASER FIBER SEPARATED. THE FIBER WAS ATTACHED TO THE LASER UNIT, AND ENERGY WAS DELIVERED THROUGH THE LASER FIBER SUCCESSFULLY. THE LASER FIBER WORKED FOR APPROXIMATELY 5 MINUTES UNTIL THE LASER FIBER BECAME VERY BRIGHT AND ENERGY WAS LOST. THE SCOPE AND FIBER WERE REMOVED, AND, UPON INSPECTION, THE LASER FIBER HAD SEPARATED INTO TWO SEGMENTS. THE FIBER BROKE WITHIN THE SCOPE WHILE IT WAS INSIDE THE PATIENT APPROXIMATELY 1.5 METERS FROM THE PROXIMAL END OF THE DEVICE. BOTH PORTIONS OF THE LASER FIBER WERE REMOVED, AND A NEW SCOPE AND FIBER WERE 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 THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378599 ↗
• InjuryJun 3, 2022Break; Break

  AS REPORTED, A COOK® SINGLE-USE HOLMIUM LASER FIBER SEPARATED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND NO DAMAGED WAS NOTED UPON INITIAL INSPECTION. THE FIBER WAS ATTACHED, DETECTED, AND THE AIMING BEAM WAS VISIBLE. THE DEVICE WAS TURNED ON AND BROKE UP A STONE WITHOUT ISSUE. UPON WITHDRAWAL OF THE DEVICE, THE USER FELT IT GET "CAUGHT" ON SOMETHING, HOWEVER, THE TUOHY BORST WAS FULLY OPEN. UPON REMOVING THE DEVICE FROM THE PATIENT, 10 TO 15 CENTIMETERS OF THE FIBER WAS MISSING. AN UNSPECIFIED STONE EXTRACTOR WAS PLACED DOWN THE FLEXIBLE SCOPE AND THE SEPARATED PORTION OF THE FIBER WAS SUCCESSFULLY RETRIEVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14593782 ↗
• MalfunctionMar 23, 2022Break; Break

  AS REPORTED, THE RED CONNECTOR COVER ON AN UNSPECIFIED HOLMIUM LASER FIBER SEPARATED FROM THE SILVER FIBER CONNECTOR AFTER THE FIBER WAS CONNECTED TO THE LASER MACHINE. THE LASER FIBER WAS DIFFICULT TO REMOVE FROM THE MACHINE, AND THE FIBER "SNAPPED" WHEN ATTEMPTING TO DISCONNECT THE FIBER FROM THE LASER MACHINE. THE FIBER WAS ABLE TO BE REMOVED FROM THE LASER MACHINE DESPITE THE SEPARATION. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863620 ↗
• MalfunctionFeb 16, 2022Break; Break

  AS REPORTED, DURING A FLEXIBLE URETEROSCOPY IN THE KIDNEY WITH STENT INSERTION, A COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE. A COOK FLEXOR ACCESS SHEATH WAS PLACED OVER A COOK HIWIRE® NITINOL CORE WIRE GUIDE, AND THE INNER DILATOR AND WIRE WERE REMOVED. ANOTHER MANUFACTURER'S FLEXIBLE SCOPE WAS PREPARED, AND THE LASER FIBER WAS REMOVED FROM THE PACKAGING. A SHARP BEND WAS NOTICED IN THE LASER FIBER APPROXIMATELY ONE CENTIMETER INTO THE BLUE COATING AT THE TIP'S END. THE FIBER WAS INSERTED INTO THE LASER UNIT, AND THE AIMING BEAM WAS TURNED ON AND READ THE FIBER. THE FIBER SHONE AT THE SHARP BEND, INDICATING THE FIBER WAS BROKEN. THE FIBER WAS REMOVED, AND ANOTHER FIBER OF THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE FAULTY LASER FIBER DID NOT MAKE PATIENT CONTACT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543249 ↗
• InjuryDec 14, 2021Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001268 ↗
• MalfunctionNov 8, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 16NOV2021: ANOTHER FIBER WAS USED TO COMPLETE THE PROCEDURE.

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

  MAUDE report 12769807 ↗
• InjuryOct 12, 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: Foreign Body In Patient

  MAUDE report 12615674 ↗
• MalfunctionSep 24, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526717 ↗