VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (REF N6007440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170458439), received between Aug 12, 2025 and Sep 1, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K221557); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Contamination; Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543597 ↗
• MalfunctionMay 22, 2026Material Deformation

  IT WAS REPORTED THE HYSTERO VIDEOSCOPE HAD A BULGE ABOUT 2 TO 3 INCHES FROM THE DISTAL TIP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254416 ↗
• MalfunctionMay 14, 2026Material Fragmentation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROVIDEOSCOPE EXHIBITED CHIPPED ADHESIVE AT THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174548 ↗
• MalfunctionMay 14, 2026Environmental Particulates

  IT WAS OBSERVED THAT THE VISERA HYSTERO VIDEOSCOPE EXHIBITED THAT THE OBJECTIVE LENS IS DIRTY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167334 ↗
• MalfunctionApr 27, 2026Crack; Material Fragmentation

  DURING THE DEVICE EVALUATION, CHIPPING AND CRACKING WERE FOUND ON THE A-RUBBER ADHESIVE, OBJECTIVE LENS ADHESIVE, AND LIGHT GUIDE LENS ADHESIVE OF THE VISERA HYSTERO VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008675 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE HYSTERO VIDEOSCOPE EXHIBITED OBJECTIVE LENS HAD CHIPPED CEMENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715475 ↗
• MalfunctionFeb 2, 2026Material Deformation

  IT WAS REPORTED THE VIDEOSCOPE HAD A BULGE BELOW THE 12 CM MARK INSIDE THE LUMEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239829 ↗
• MalfunctionNov 20, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605652 ↗
• MalfunctionNov 10, 2025Material Integrity Problem; Material Integrity Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512182 ↗
• MalfunctionNov 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED RUST ON THE PLASTIC END DISTAL COVER AND THE METAL RING NEAR THE BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452852 ↗
• MalfunctionOct 20, 2025Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED THE SUBJECT FLEX VIDEO SCOPE DEVICE HAD BULGING INSIDE THE LUMEN. THERE WAS NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23338504 ↗
• MalfunctionAug 12, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BULGE INSIDE THE LUMEN. THERE ARE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790379 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221557. One submission often covers many models, so check the product and lot details in each record.

• Z-0336-2024 · Sep 25, 2023 · Open, Classified
  Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
• Z-2480-2023 · Jul 20, 2023 · Open, Classified
  Visera Hysterovideoscope Olympus HYF Type V