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

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04953170340185), received between Apr 13, 2022 and Sep 22, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (8 reports).

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

1 other recall 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.

Recalls naming this device

1. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0336-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Material Split, Cut or Torn

  The customer returned the hysterovideoscope to the service center for a separate issue. During the device analysis, the device evaluator indicated that a torn bending section cover was found. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858885 ↗
• MalfunctionAug 11, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204678 ↗
• MalfunctionJul 20, 2026Corroded

  THE CUSTOMER RETURNED THE HYSTERO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE OLYMPUS SERVICE REPAIR TECHNICIAN INDICATED THAT CORROSION ON THE DISTAL END AND CORROSION ON THE FORCEPS CHANNEL PORT WAS FOUND. IT WAS DETERMINED THAT THE DISTAL END AND THE FORCEPS CHANNEL PORT NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25871637 ↗
• MalfunctionJun 25, 2026Material Separation

  THE CUSTOMER RETURNED THE HYSTERO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT THE BENDING SECTION COVER IS OFF WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627763 ↗
• MalfunctionApr 21, 2026Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VISERA HYSTERO VIDEOSCOPE HAD FOREIGN MATERIAL PASSING FROM THE BODY CONTROL UNIT TOWARD THE SCOPE CONNECTOR, FOREIGN MATERIAL PASSING FROM THE BODY CONTROL UNIT SUCTION CYLINDER TOWARD THE DISTAL END, AND FOREIGN MATERIAL PASSING FROM THE BIOPSY PORT TOWARD THE DISTAL END. ADDITIONALLY, FOREIGN MATERIAL WAS EXPELLED AFTER CLEANING THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940114 ↗
• MalfunctionApr 2, 2026Powder Leak

  IT WAS REPORTED THE VIDEOSCOPE HAD A WHITE POWDER COMING OUT OF THE SHEATH. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769071 ↗
• MalfunctionMar 23, 2026Unintended Movement

  IT WAS REPORTED THE VIDEOSCOPE INSERTION PORT WAS LOOSE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663394 ↗
• MalfunctionJan 28, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTERO VIDEOSCOPE EXHIBITED FOREIGN MATERIAL CLOGGING THE CHANNEL TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199164 ↗
• MalfunctionOct 23, 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 MISSING ADHESIVE AROUND THE LIGHT GUIDE LENS AND A PEELED ADHESIVE AT THE OBJECTIVE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375710 ↗
• MalfunctionSep 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE BENDING SECTION OF HYSTEOVIDEOSCOPE WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016233 ↗
• MalfunctionAug 5, 2025Corroded; Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THERE WAS STICKINESS ON THE CONTROL PANEL, UNIVERSAL CORD, AND CONNECTING TUBE OF THE HYSTERO VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713933 ↗
• MalfunctionMar 27, 2025Material Separation; Material Separation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROVIDEOSCOPE EXHIBITED PART FELL OFF FROM THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708437 ↗
• MalfunctionOct 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE SCOPE COVER AND FORCEPS CHANNEL OF THE HYSTEROVIDEOSCOPE HAD FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396942 ↗
• MalfunctionSep 27, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE VISERA HYSTEROSCOPE HAD TIP BROKEN AS NOZZLE WAS NOT ATTACHED DURING STERILIZATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328661 ↗
• MalfunctionSep 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED, DURING DEVICE EVALUATION. THAT THE DISTAL SHEATH OF THE VISERA HYSTEROVIDEOSCOPE HAD FALLEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185415 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE HYSTEROVIDEOSCOPE EXHIBITED THE OBJECTIVE LENS HAS FALLEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077621 ↗
• MalfunctionAug 21, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED, THE HYSTEROVIDEOSCOPE HAS A WIRE-LIKE PART PROTRUDING FROM THE TIP OF THE SCOPE. THE ISSUE OCCURRED, DURING REPROCESSING. AFTER A THERAPEUTIC HYSTEROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011346 ↗
• MalfunctionJul 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE HYSTEROVIDEOSCOPE EXHIBITED THE BENDING SECTION COVER HAVING A CUT WITH A PROTRUDING PIN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755351 ↗
• MalfunctionJul 1, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE HYSTEROVIDEOSCOPE BEDSIDE PRECLEANING WAS NOT BEING PERFORMED. THE CUSTOMER WAS EDUCATED ON PROPER BEDSIDE PRECLEANING IMMEDIATELY POST-PROCEDURE. THE CUSTOMER HAS PLAN IN PLACE TO BEGIN PROPER BEDSIDE PRECLEANING PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651313 ↗
• MalfunctionJan 25, 2024Peeled/Delaminated; Component Missing; Peeled/Delaminated; Component Missing

  THE CUSTOMER REPORTED TO OLYMPUS, THE HYSTEROVIDEOSCOPE HAD A TEAR IN THE COATING AT THE TIP. THE ISSUE WAS FOUND DURING PREPARATION FOR USE, THE TEST WAS DISCONTINUED WITH NO PATIENT HEALTH DAMAGE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE TIP COMPONENT WAS MISSING (INCLUDING BENDING SECTION COVER). THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581644 ↗
• MalfunctionJan 3, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE HYSTEROVIDEOSCOPE, THE UNIT HAD DIRT THAT CANNOT BE REMOVED FROM THE TIP OF THE FORCEPS OPENING. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION FOUND FOREIGN OBJECT CAME OUT OF THE FORCEPS CHANNEL. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436018 ↗
• MalfunctionDec 22, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED TO OLYMPUS, THE HYSTEROVIDEOSCOPE BIOPSY PORT SPUN, MAKING IT DIFFICULT TO REMOVE THE STOP COCK WHEN ATTACHED. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO DELAY TO THE PROCEDURE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381019 ↗
• MalfunctionDec 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA HYSTEROVIDEOSCOPE HAD BUCKLING OF THE INSERTION PART. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE METAL WAS FOUND TO BE PROTRUDING FROM THE PERFORATION IN THE BENDING SECTION COVER DUE TO THE BREAKAGE OF THE CURVED TUBE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325116 ↗
• MalfunctionDec 11, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED TO OLYMPUS, THE HYSTEROVIDEOSCOPE SCOPE WAS UNRECOGNIZED AND THE FORCEPS WERE MISSING. THE ISSUE WAS FOUND DURING RECEIPT INSPECTION. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE FORCEPS CHANNEL PORT WAS NOT SECURED. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18305010 ↗
• MalfunctionDec 4, 2023Device Reprocessing Problem; Device Reprocessing Problem

  DURING AN ONSITE IN-SERVICE DEMONSTRATION BY AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS), IT WAS NOTED THAT THE USER FACILITY STAFF WAS NOT LEAKING TESTING THE HYSTEROVIDEOSCOPE; HAD NOT BEEN BRUSHING THE CHANNEL OF THE HYSTEROVIDEOSCOPE; AND THEY DID NOT IMMERSE THE LIGHT GUIDE OR CONNECTORS IN THE HIGH LEVEL DISINFECTANT. THERE WERE NO REPORTS OF PATIENT INFECTIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256505 ↗

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-2480-2023 · Jul 20, 2023 · Open, Classified
  Visera Hysterovideoscope Olympus HYF Type V