n.a. 11272VNURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551226193), received between Apr 10, 2018 and Apr 10, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 1, 2022Open, Classified

   Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

   Z-1064-2022 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryApr 10, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ALLEGEDLY, THE PHYSICIAN PERFORMED A CYSTOSCOPY PROCEDURE ON PATIENT. POST THE PROCEDURE, PATIENT WAS ADMITTED TO THE ICU. PATIENT'S URINE WAS CULTURED WHICH CONFIRMED PSEUDOMONAS AERUGINOSA INFECTION. PATIENT WAS TREATED BY AN OUTSIDE DOCTOR. THE CLINIC DOES NOT HAVE ANY INFORMATION ON TREATMENT, BUT MOST LIKELY THE PATIENT RECEIVED ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 7418170 ↗
• InjuryApr 10, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ALLEGEDLY, THE PHYSICIAN PERFORMED A CYSTOSCOPY PROCEDURE ON PATIENT. PATIENT'S URINE WAS CULTURED AND PSEUDOMONAS AERUGINOSA INFECTION WAS CONFIRMED FROM THE LAB RESULTS. PATIENT WAS TREATED WITH ANTIBIOTICS FROM A DOCTOR OUTSIDE OF THE CLINIC. THE DOCTOR REPORTED THAT PATIENT IS DOING FINE.

  Patient problems: Bacterial Infection

  MAUDE report 7418124 ↗
• InjuryApr 10, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ALLEGEDLY, THE PHYSICIAN PERFORMED A CYSTOSCOPY PROCEDURE ON PATIENT. PATIENT'S URINE WAS CULTURED AND PSEUDOMONAS AERUGINOSA INFECTION WAS CONFIRMED FROM THE LAB RESULTS. PATIENT WAS TREATED WITH ANTIBIOTICS FROM A DOCTOR OUTSIDE OF THE CLINIC. THE DOCTOR REPORTED THAT PATIENT IS DOING FINE.

  Patient problems: Bacterial Infection

  MAUDE report 7418116 ↗
• InjuryApr 10, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ALLEGEDLY, THE PHYSICIAN PERFORMED A CYSTOSCOPY PROCEDURE ON PATIENT. PATIENT'S URINE WAS CULTURED AND PSEUDOMONAS AERUGINOSA INFECTION WAS CONFIRMED FROM THE LAB RESULTS. PATIENT WAS TREATED WITH ANTIBIOTICS FROM A DOCTOR OUTSIDE OF THE CLINIC. THE DOCTOR REPORTED THAT PATIENT IS DOING FINE.

  Patient problems: Bacterial Infection

  MAUDE report 7418096 ↗