Cook G14090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002140905), received between Nov 28, 2018 and Nov 15, 2023 — classified as 4 malfunctions.

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

• MalfunctionNov 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, CONTAMINATION WAS FOUND INSIDE THE PACKAGE OF THE URETERAL BRUSH BIOPSY SET PRIOR TO A URETERAL BIOPSY PROCEDURE. THE PACKAGE WAS NOT OPENED, AND THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141233 ↗
• MalfunctionJan 3, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, A RED, RUST LIKE MATERIAL WAS DISCOVERED INSIDE THE UNOPENED PACKAGE OF A URETERAL BRUSH BIOPSY SET. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9544565 ↗
• MalfunctionNov 29, 2018Break; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE USER OPENED THE PACKAGE, IT WAS NOTED A KINK IN THE URETERAL BRUSH BIOPSY SET. HOWEVER, IT WAS FURTHER NOTED THAT THE COIL WAS BROKEN NEAR THE BRUSH AREA. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE. A NEW PRODUCT WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8115308 ↗
• MalfunctionNov 28, 2018Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE USER OPENED THE PACKAGE, IT WAS NOTED THAT THE TIP OF URETERAL BRUSH WAS BENT. IT WAS FURTHER NOTED THAT THE COIL HAD BEEN UNWOVEN AND WAS IN A DAMAGED STATE. ANOTHER DEVICE WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8111133 ↗