Cook G17909Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002179097), received between Feb 16, 2021 and Aug 9, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 9, 2024Material Separation; Material Separation

  IT WAS REPORTED "A PIECE" OF THE INTEGRAL FILIFORM URETHRAL DILATOR BROKE OFF DURING A URETHRAL DILATION PROCEDURE ON (B)(6) 2024. ON FEBRUARY 14, 2024, THE PATIENT UNDERWENT A OPTICAL URETHROTOMY AND SCOPE PROCEDURE FOR TREATMENT OF URETHRAL STRICTURE. FOLLOWING THE PROCEDURE, THE DEVICE COULD BE ADVANCED WITHOUT DIFFICULTY ALLOWING THE PATIENT TO SELF-DILATE AS NEEDED AT HOME. IN JULY, AS THE PATIENT PERFORMED A SELF-URETHRAL DILATION PROCEDURE AT THE PATIENT¿S RESIDENCE, THE DEVICE SEPARATED IN THE PATIENT¿S URETHRA. THE SEPARATED SECTION OF THE DEVICE WAS REMOVED BY THE PATIENT WITHOUT THE USE OF ANY ADDITIONAL INSTRUMENTS. 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 19955981 ↗
• MalfunctionFeb 16, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Pain

  MAUDE report 11331558 ↗