CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHR (REF N3828633)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170434730), received between May 28, 2024 and May 5, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Flaked” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K221683); they may or may not involve this specific model.

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 18, 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.

• MalfunctionMay 5, 2026Loss of or Failure to Bond

  THE CUSTOMER DID NOT REPORT A MALFUNCTION. DURING AN INSPECTION OF THE ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE, THE ADHESIVE ON A-RUBBER BENDING SECTION HAD A CHIP FOUND. THE MOST LIKELY CAUSE OR PROBABLE CAUSE OF THE REPORTABLE MALFUNCTION IS DETERIORATION OR BREAKAGE OF THE ADHESIVE (CHEMICAL STRESS / PHYSICAL STRESS). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089772 ↗
• InjuryMay 28, 2024Flaked; Flaked

  IT WAS REPORTED, DURING THE THERAPEUTIC CYSTOSCOPY, DEBRIS FROM THE CYSTO-NEPHRO VIDEOSCOPE FELL INTO THE PATIENT'S BLADDER. THERE WAS A PROCEDURAL DELAY WHILE THE DOCTOR TRIED TO BASKET THE DEBRIS OUT BUT COULD NOT CATCH THE DEBRIS IN THE NON-OLYMPUS BASKET. THE PATIENT URINATED THE DEBRIS OUT AND IS IN GOOD STANDING. ANOTHER CYSTOSCOPY WAS PERFORMED LAST WEEK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE OUTCOME WAS NOT AFFECTED AS A RESULT OF THE ISSUE. THE DEVICE WAS INSPECTED BEFORE USE AND APPEARED TO BE NORMAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 19403927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221683. One submission often covers many models, so check the product and lot details in each record.

• Z-0690-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
• Z-0691-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
• Z-0692-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
• Z-0689-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
• Z-0331-2024 · Sep 25, 2023 · Open, Classified
  Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.