VISERA HYSTEROVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one VISERA HYSTEROVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 75
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of VISERA HYSTEROVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Apr 13, 2022 and Sep 22, 2026 — classified as 75 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
VISERA HYSTEROVIDEOSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 VISERA HYSTEROVIDEOSCOPE problems
Device problems
- Detachment of Device or Device Component17
- Material Split, Cut or Torn10
- Loose or Intermittent Connection8
- Device Reprocessing Problem5
- Peeled/Delaminated5
- Break4
- Material Deformation4
- Material Separation4
Patient problems
- No Clinical Signs, Symptoms or Conditions75
VISERA HYSTEROVIDEOSCOPE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE VHYSTEROSCOPE (AND ACCESSORIES)1 recall48 reports
- VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE VHYSTEROSCOPE (AND ACCESSORIES)15 reports
- VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE VHysteroscope (And Accessories)12 reports
Recent VISERA HYSTEROVIDEOSCOPE adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 1, 2026Contamination; Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543597 ↗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 ↗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 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 ↗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 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 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 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 ↗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 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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