Brooks 91-9350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932627320), received between May 23, 2023 and Jul 30, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionJul 30, 2024Material Separation; Material Separation

  ACCORDING TO THE AVAILABLE INFORMATION, THIS BROOKS DILATOR TIP BROKE DURING REPROCESSING. THE NUMBER OF REPROCESSING CYCLES UNKNOWN. COLOPLAST TERRITORY MANAGER INDICATES HE WAS ISSUED A SET OF BROOKS DILATORS WHEN HE STARTED IN 2015; HOWEVER, THE SET WAS SWITCHED WITH ANOTHER SET AT ANOTHER HOSPITAL. HE INDICATED "MENTOR" WAS ON THIS HANDLE VERSUS "COLOPLAST" ON HIS SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19865759 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WITH THIS DEVICE EXPERIENCED A URETHRAL PERFORATION. THIS DEVICE WAS USED TO DILATE THE PATIENT FOR ANOTHER DEVICE IMPLANT. ONLY THE RESERVOIR WAS ABLE TO BE IMPLANTED AND THE PROCEDURE WAS ABORTED DUE TO THE PERFORATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 16983384 ↗