Cook G23733Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002237339), received between Nov 11, 2016 and Aug 3, 2018 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2018Break; Defective Device

  THE COMPLAINANT REPORTED THAT THE SINGLE-USE HOLMIUM LASER FIBER WAS DEFECTIVE. IT WAS FURTHER NOTED THAT THE FIBER OPTICS WAS BROKEN 10.2CM(CENTIMETERS) AND 30.5CM(CENTIMETERS) FROM THE DISTAL TIP. 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 7746828 ↗
• MalfunctionAug 2, 2018Loss of Power; Structural Problem

  IT WAS REPORTED THAT THE SINGLE-USE HOLMIUM LASER FIBER STOPPED WORKING AFTER APPROXIMATELY 5 MINUTES OF LASERING THE STONE, AND THAT THE AIMING BEAM DISAPPEARED. IT WAS ALSO FOUND THAT THE CLADDING WAS SCRAPED AND CUT APPROXIMATELY 12CM FROM THE DISTAL TIP, EXPOSING THE FIBER. THE CASE WAS COMPLETED WITH ANOTHER FIBER, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7743185 ↗
• MalfunctionMay 19, 2017Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN UNSPECIFIED PROCEDURE ON A PATIENT BY USING COOK® SINGLE-USE HOLMIUM LASER FIBER. DURING THE PROCEDURE, THE FIBER BROKE INSIDE OF THE SCOPE UNDER LOW POWER. THE PHYSICIAN PULLED OUT THE BROKEN FIBER AND COMPLETED THE PROCEDURE WITH A SECOND LASER FIBER. 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 6577874 ↗
• InjuryApr 26, 2017Material Separation; Material Separation

  THE CUSTOMER STATED THAT DURING A UROLOGY CASE, A LASER WAS BEING USED AND WHILE LASING A 5 MM STONE IN THE URETEROPELVIC JUNCTION (UPJ) ON THE RIGHT SIDE WITH A 200 MICRON FIBER, A SMALL PIECE OF THE FIBER TIP BROKE OFF INTO THE PATIENT. IT WAS REPORTED TO BE APPROXIMATELY AROUND 2 MM. IT WAS REPORTED THAT THE PHYSICIAN SEARCHED FOR THE TIP AND FEELS IT EITHER CAME OUT WITH THE SHEATH OR THE PATIENT WILL VOID IT DUE TO ITS SMALL SIZE. THERE WERE NO ADDITIONAL PROCEDURES PERFORMED, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6521680 ↗
• InjuryApr 5, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN REMOVED THE BROKEN PIECE OF COOK SINGLE-USE HOLMIUM LASER FIBER FROM THE PATIENT USING A BASKET. COOK RHAPSODY H-30 LASER MACHINE WAS USE TO PERFORM THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE BUT IT EXTENDED OPERATING ROOM AND ANESTHESIA TIME FOR THE PATIENT BY FEW MINUTES. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6460094 ↗
• InjuryNov 11, 2016Material Separation; Material Separation

  DURING PROCEDURE STAFF NOTED THAT THE TIP OF THE FIBRE HAD BROKEN OFF INTO THE PATIENT. ATTEMPTS WERE MADE TO RETRIEVE THE TIP, HOWEVER THIS WAS UNSUCCESSFUL. ANOTHER FIBRE HAD TO BE OPENED SO THAT THE PROCEDURE COULD BE COMPLETED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6096916 ↗