Cook G23552Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002235526), received between Mar 23, 2018 and Oct 16, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 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 20464959 ↗
• MalfunctionApr 19, 2024Break; Break

  AS REPORTED, THE COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE INTO TWO PIECES (APPROXIMATELY IN THE MIDDLE) AFTER CONNECTING TO THE LASER MACHINE DURING A RIGID URETEROSCOPY AND A URETERAL LITHOTRIPSY PROCEDURE. THE PROCEDURE WAS COMPLETE WITH A NEW SAME-LIKE DEVICE. THE DEVICE WAS NOT INSPECTED FOR DAMAGE PRIOR TO USE. THE AIMING BEAM APPEARED CLEAR AND ROUNDED/OVAL PRIOR TO USE. DURING THE PROCEDURE, THE POWER SETTING WERE SET TO ENERGY/PULSE (J/P) 0.5J, REPETITION RATE (HZ) 12HZ, TOTAL ENERGY (J) 6W. IT WAS REPORTED THAT MANIPULATION THAT MAY HAVE CAUSED DAMAGE TO THE FIBER DID NOT OCCUR. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19146140 ↗
• MalfunctionMay 5, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  AS REPORTED, A COOK SINGLE-USE HOLMIUM LASER FIBER BROKE WHEN CONNECTED TO THE LASER UNIT. THE INITIAL PHOTO PROVIDED BY THE USER FACILITY SHOWED THE RED CONNECTOR SEPARATED FROM THE LASER FIBER ASSEMBLY. UPON RETURN OF THE DEVICE AND SUBSEQUENT INVESTIGATION ON (B)(6) 2022, IT WAS NOTED THAT THE FIBER SHAFT SEPARATED INTO TWO PIECES NEAR THE CONNECTION HUB. 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 ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289895 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

  AS REPORTED, DURING A URETEROSCOPY (URS), THE TIP OF A COOK® SINGLE-USE HOLMIUM LASER FIBER, BROKE AFTER FIVE MINUTES OF USE. THE FIBER WAS USED WITH THE PATIENT AND PATIENT WAS NOT INJURED. AN EXTRACTOR WAS USED TO RETRIEVE THE TIP OF THE FIBER FROM THE URETER. 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 11620043 ↗
• MalfunctionDec 5, 2020Material Separation; Material Separation

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10953250 ↗
• MalfunctionDec 3, 2019Fracture; Fracture

  ADDITIONAL INFORMATION REGARDING THE PATIENT WAS RECEIVED ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT "HAD A LARGE STONE" AND WOULD "PROBABLY HAVE NEEDED 2 SESSIONS". THE PHYSICIAN'S TENTATIVE PLAN IS TO REMOVE THE FIBER FRAGMENT DURING THE PATIENT'S NEXT SESSION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9405028 ↗
• MalfunctionSep 19, 2018Crack; Crack

  IT WAS REPORTED, THEY WERE GETTING READY TO DO LASER LITHOTRIPSY, THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS INSERTED INTO THE SCOPE AND THEY NOTICED THE TIP OF THE FIBER WAS CRACKED. THE CRACKED FIBER DID NOT MAKE PATIENT CONTACT. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889216 ↗
• MalfunctionAug 2, 2018Break; Material Twisted/Bent

  THE COMPLAINANT REPORTED THAT THE STONE WAS NOT DESTROYED EVEN AFTER APPROXIMATELY 10 MINUTES OF USE AND 2 ENERGY INCREASES. AS A RESULT, THE SINGLE-USE HOLMIUM LASER FIBER WAS REMOVED, AND NOTED TO BE BROKEN APPROXIMATELY 40 CM (CENTIMETERS) FROM THE TIP. IT WAS FURTHER NOTED THAT THE FIBER OPTICS WAS SEPARATED WITH THE SHEATH TWISTED AND SPLIT. 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 7742582 ↗
• MalfunctionMar 23, 2018Break; Break

  IT WAS REPORTED THE COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE INSIDE THE URETEROSCOPE. ALL DEVICE COMPONENTS REMAINED INSIDE THE SCOPE AND THE SCOPE WAS REMOVED. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7366999 ↗