Cook G23668Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10827002236681), received between Dec 5, 2018 and Jan 9, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED A COOK® MULTI-USE HOLMIUM LASER FIBER BROKE IN TWO PIECES DURING A URETEROSCOPY PROCEDURE AFTER 6 USAGES. THE FIBER BROKE OUTSIDE OF THE PATIENT. THE USER COULD NOT FINISH BREAKING ALL STONES CAUSING A DELAY IN THE PROCEDURE; THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE. THE DEVICE WAS CLEANED BETWEEN USES WITH CIDEX SOLUTION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21115466 ↗
• MalfunctionJan 8, 2025Break; 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 21105203 ↗
• MalfunctionNov 23, 2024Break; Break

  AS REPORTED, DURING A RETROGRADE INTRARENAL SURGERY (RIRS) IN THE KIDNEY, A COOK® MULTI-USE HOLMIUM LASER FIBER BROKE AT THE CONNECTOR. THE USE OF THE FIBER WAS DISCONTINUED. THEY OPEN A NEW UNIT OF HOLMIUM LASER FIBER TO COMPLETE THE PROCEDURE. ATTACHED PHOTO SHOWS FIBER BROKE AT THE CONNECTOR. 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 20766984 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THE 'COOK MULTI-USE HOLMIUM LASER FIBER' BROKE DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE IN THE KIDNEY. 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 REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077986 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT THE GREEN LASER LIGHT WAS VISIBLE THROUGH THE BLUE COATING OF A COOK® MULTI-USE HOLMIUM LASER FIBER. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. 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 17835927 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT THE GREEN LASER LIGHT WAS VISIBLE THROUGH THE BLUE COATING OF A COOK® MULTI-USE HOLMIUM LASER FIBER. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. 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 17835713 ↗
• MalfunctionDec 20, 2021Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042977 ↗
• MalfunctionOct 13, 2021Material Separation; Material Separation

  AS REPORTED, DURING A URETEROSCOPY AND USING A COOK MULTI-USE HOLMIUM LASER FIBER, THE FIBER TIP BROKE OFF DURING THE CASE. THE FIBER WAS INSPECTED BEFORE USE AND NO DAMAGE WAS NOTED AT THAT TIME. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623478 ↗
• MalfunctionMar 18, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS INITIALLY REPORTED, TWO COOK® MULTI-USE HOLMIUM LASER FIBERS WERE DAMAGED AFTER DISINFECTION. DURING A FLEXIBLE URETEROSCOPY, THE DOCTOR NOTICED THAT THE FIBERS PRESENT MANY "RIFTS" THE "RIFTS" WERE LOCATED ON THE LASER FIBER BODIES. THE ISSUE WITH THE DEVICES WAS DISCOVERED PRIOR TO MAKING CONTACT WITH THE PATIENT AND THEY WERE NOT USED. THE DEVICES WERE RETURNED TO THE MANUFACTURER AND EVALUATION OF THE RETURNED DEVICES ON 25FEB2021 DETERMINED BOTH FIBERS WERE SEPARATED. 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 11514572 ↗
• MalfunctionDec 21, 2020Material Separation; Device Damaged Prior to Use; Material Separation; Device Damaged Prior to Use

  IT WAS REPORTED, AFTER COMPLETING RETROGRADE INTRARENAL SURGERY (RIRS), WHEN REMOVING THE COOK® MULTI-USE HOLMIUM LASER FIBER, THE BLUE PLASTIC OUTER PART OF THE FIBER SEPARATED FROM THE INNER PART OF IT. 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; No Consequences Or Impact To Patient

  MAUDE report 11050157 ↗
• MalfunctionJul 29, 2020Fracture; Fracture

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

  Patient problems: No Patient Involvement

  MAUDE report 10339121 ↗
• MalfunctionJul 1, 2020Material Separation; Material Separation

  IT WAS INITIALLY REPORTED, DURING A URETEROSCOPY TO REMOVE A URETER STONE BY USING LASER LITHOTRIPSY, THE AIMING BEAM OF A COOK® MULTI-USE HOLMIUM LASER FIBER WAS "OFF" IN THE MIDST OF LITHOTRIPSY. THERE WAS NO ERROR MESSAGE THAT CAME UP. THEY WERE ABLE TO CONTINUE THE PROCEDURE WITH A NEW MULTI-USE LASER FIBER. THE DEVICE WAS RETURNED 18JUN2020 AND IT WAS DISCOVERED THE TIP WAS BROKEN OFF. NO PIECE OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECT(S) ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10220717 ↗
• MalfunctionDec 5, 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 8133559 ↗