Cook G14731Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002147317), received between Aug 1, 2016 and Jun 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Fracture; Fracture

  IT WAS REPORTED; UPON REMOVAL THE STANDARD FIXED CORE WIRE GUIDE CAME OUT IN TWO PIECES DURING AN UNSPECIFIED PROCEDURE. 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 HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306902 ↗
• MalfunctionOct 3, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  AS REPORTED, DURING A FLEXIBLE CYSTOSCOPY AND STENT PLACEMENT THE TIP OF A STANDARD FIXED CORE WIRE GUIDE DETACHED AND BEGAN TO UNRAVEL. THE PHYSICIAN THEN USED THE WIRE THAT WAS PROVIDED WITH THE STENT SET TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566600 ↗
• MalfunctionAug 7, 2019Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED 12 AUG 2019: THE CONCOMITANT DEVICES USED DURING THE PROCEDURE WERE A LONG TAPER URETERAL DILATOR AND A FLEXIBLE SCOPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8871651 ↗
• MalfunctionApr 12, 2018Bent

  THE COMPLAINANT REPORTED THAT THERE WAS A BEND IN THE TIP OF THE STANDARD FIXED CORE WIRE GUIDE UPON OPENING THE PACKAGE. IT WAS FURTHER NOTED THAT THE WIRE GUIDE COIL HAD A BREAK AT 3.5 CM (CENTIMETERS) FROM THE DISTAL TIP, AND THE WIRE PENETRATED THROUGH THE BROKEN COIL. THIS PRODUCT PROBLEM WAS NOTED PRIOR TO PATIENT CONTACT, AND ANOTHER DEVICE WAS USED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427413 ↗
• MalfunctionMay 17, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  THE CUSTOMER REPORTED THAT THE TIP OF STANDARD FIXED CORE WIRE GUIDE WAS FOUND BROKEN WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT HARM REPORTED AND NO ADDITIONAL PROCEDURES WERE REQUIRED BECAUSE OF THIS FAILURE. IT WAS FURTHER REPORTED THAT THE CUSTOMER DROPPED THE DEVICE PACKAGE AND THEREFORE, THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6572590 ↗
• MalfunctionAug 1, 2016Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, TWO WIRES WERE PLACED. UPON ADVANCING THE SCOPE ONTO THE WORKING WIRE, IT WAS NOTED THAT THE WIRE WAS BROKEN AT THE 3MM TIP AND THE METAL PIECE WAS EXPOSED. A SECOND WIRE WAS USED AND THE SAME ISSUE OCCURRED. AFTER REMOVING THE TWO WIRES, IT WAS REPORTED THAT THE STATIONARY WIRE WAS BENT. AN UNUSED WIRE FROM THE PACKAGING WAS EXAMINED AND WHEN PLACING THE DEMO WIRE INTO THE CASING, THE TIP BENT AND WAS PERMANENTLY DAMAGED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL SURGICAL OR MEDICAL INTERVENTION DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5836097 ↗