Cook G14255Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002142558), received between Sep 18, 2023 and Sep 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS DIFFICULT TO REMOVE FROM A DISPOSABLE TWO-PART TROCAR NEEDLE. THE WIRE GUIDE WAS PLACED UNDER X-RAY THROUGH THE SHEATH OF THE TROCAR NEEDLE DURING A LEFT SUPINE PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE FOR AN UNKNOWN PATIENT. ACCESS TO THE KIDNEY WAS ACHIEVED, AND THE INNER TROCAR OF THE NEEDLE WAS REMOVED BEFORE PLACING THE WIRE GUIDE THROUGH THE OUTER SHEATH OF THE NEEDLE. NO RESISTANCE WAS REPORTED. THE WIRE WAS MANIPULATED IN ORDER TO PLACE THE WIRE DOWN THE URETER. HOWEVER, IN THIS PROCESS THE WIRE WOULD NOT MOVE ANY MORE. ATTEMPTED WITHDRAW OF THE WIRE GUIDE WAS UNSUCCESSFUL. THEREFORE, THEY ATTEMPTED TO PULL THE WIRE THROUGH VIA A RETROGRADE APPROACH USING ANOTHER MANUFACTURER'S DISPOSABLE URETEROSCOPE AND A COOK FLEXOR URETERAL ACCESS SHEATH. FURTHER ATTEMPTS TO WITHDRAW THE WIRE VIA A NEEDLE SHEATH REVEALED THE COATING HAD BEEN STRIPPED FROM THE WIRE LEAVING A BARE WIRE SECTION. DILATION WAS CONTINUED WITH FASCIAL DILATOR SETS FOLLOWED BY A NEPHROSTOMY BALLOON CATHETER. A DUAL LUMEN URETERAL ACCESS CATHETER WAS USED TO EXCHANGE THE WIRE FOR A NEW WIRE GUIDE. WHEN THE NEEDLE AND SHEATH WERE PUT BACK TOGETHER ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770546 ↗