Cook G14919Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002149199), received between Jun 2, 2021 and Jan 7, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJan 7, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR-LIKE FOREIGN MATTER WAS NOTED INSIDE A SEALED URETERAL BRUSH BIOPSY SET PACKAGE. THIS WAS NOTED PRIOR TO OPENING AND PRIOR TO PATIENT USE/CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193957 ↗
• MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11922229 ↗