VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (REF N6007430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04953170411564), received between Mar 9, 2023 and Jul 8, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753277 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  THE CUSTOMER RETURNED THE HYSTEROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE LIGHT GUIDE LENS HAD CHIPPED CEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25631316 ↗
• MalfunctionJun 22, 2026Peeled/Delaminated

  IT WAS REPORTED THE VIDEOSCOPE BLACK PLASTIC COTING WAS COMING OFF/PEELED OFF OF THE INSERTION TUBE. THE ISSUE WAS DISCOVERED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25585449 ↗
• MalfunctionMay 26, 2026Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTERO VIDEOSCOPE EXHIBITED A CHIP ON LIGHT GUIDE LENS ADHESIVE, AND RUST ON THE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280222 ↗
• MalfunctionMay 19, 2026Material Separation; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROVIDEOSCOPE EXHIBITED A DETACHED OBJECTIVE LENS, AND MISSING ADHESIVE FROM THE BENDING SECTION COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217562 ↗
• MalfunctionMay 13, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CUSTOMER'S VIDEOSCOPE DEVICE HAD CHIPPED BENDING SECTION COVER ADHESIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162263 ↗
• MalfunctionMay 6, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTERO VIDEOSCOPE HAD A CHIPPED DISTAL SHEATH ADHESIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095202 ↗
• MalfunctionMar 24, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTERO VIDEOSCOPE EXHIBITED DETACHED BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679488 ↗
• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647753 ↗
• MalfunctionNov 13, 2025Detachment of Device or Device Component; Gas/Air Leak; Material Deformation; Material Split, Cut or Torn; Detachment of Device or Device Component; Gas/Air Leak; Material Deformation; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A LEAK ON DISTAL END (A-RUBBER) CAUSED BY A CUT AND DETACHED BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539439 ↗
• MalfunctionOct 31, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE EXHIBITED EXCESSIVE PEELING AT SHEATH ON INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437331 ↗
• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED MISSING BENDING SECTION COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426650 ↗
• MalfunctionOct 27, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VISERA HYSTEROVIDEOSCOPE EXHIBITED A PEELING AND MISSING ADHESIVE ON THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391806 ↗
• MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VISERA HYSTEROVIDEOSCOPE HAD A MISSING BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23374670 ↗
• MalfunctionMar 9, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING AN UNSPECIFIED PROCEDURE THE VISERA HYSTEROVIDEOSCOPE INSERTION SECTION WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING EVALUATION OF THE RETURNED DEVICE, THE EVALUATION FOUND THAT THE FORCEP STOPPER CAP WAS SCRAPING. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518920 ↗

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