Cook G14873Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002148734), received between May 11, 2017 and May 12, 2017 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMay 12, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  THE CUSTOMER REPORTED THAT THE TIP OF SPIRAL TIP URETERAL ACCESS CATHETER WAS FOUND BROKEN PRIOR TO USE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6563101 ↗
• InjuryMay 11, 2017Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING URETEROSCOPY PROCEDURE ON A PATIENT BY USING SPIRAL TIP URETERAL ACCESS CATHETER. DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN DRAINED THE PATIENT'S BLADDER TO REMOVE THE BROKEN PIECE OF THE TIP. 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 6559967 ↗