VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2 (REF N6005730)Recalls & reported problems
Olympus Medical Systems Corp. · VISERA CYSTO-NEPHRO VIDEOSCOPE · Class 2
All models of VISERA CYSTO-NEPHRO VIDEOSCOPE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus Visera Cysto-Nephro videoscope is used to look inside the bladder and kidney. Its 409 adverse event reports often describe parts coming loose, cleaning that is not thorough, and corrosion, and some describe urinary tract infections. The reports include no deaths and 66 injuries. One recall is open, from December 2023, over cleaning instructions that no longer include reusable brushes. Reports rose from 79 in the earlier year to 206 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 418
- Deaths reported
- 0
- Injuries reported
- 66
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 418 adverse event reports that list this exact device (DI 04953170411199), received between Jul 10, 2020 and Sep 30, 2026 — classified as 66 injuries, 352 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (95 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 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.
Reports received per month
Recalls naming this device
- Dec 4, 2023Class IIOpen, Classified
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Z-0691-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component95
- Failure to Clean Adequately92
- Corroded43
- Device Reprocessing Problem37
- Break25
- Peeled/Delaminated24
- Material Split, Cut or Torn22
- Material Fragmentation19
Patient problems
- No Clinical Signs, Symptoms or Conditions346
- Urinary Tract Infection59
- Bacterial Infection4
- Burning Sensation3
- No Patient Involvement2
- Unspecified Infection2
- Dysuria1
- Hematuria1
Recent adverse event reports
The 25 most recent of 418 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955199 ↗MalfunctionSep 29, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940934 ↗MalfunctionSep 29, 2026Material Fragmentation
The customer reported that the Visera Cysto-Nephro Videoscope had a separate issue. During the initial evaluation of the device, was observed that the adhesive on the bending section was chipped. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934113 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
The cysto-nephro videoscope was returned to the service center for a separate issue. During inspection of the device, the bending section sheath was found to be detached, likely due to stress, and was repaired. There was no patient involvement, and no harm was reported as a result of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899097 ↗MalfunctionSep 21, 2026Stretched; Mechanical Jam
The customer reported the Cysto-Nephro Videoscope had a separate issue. During the initial evaluation of the device it was observed, that the bending section rubber was stretched and the control knob had no movement. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838671 ↗MalfunctionSep 3, 2026Material Fragmentation; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595609 ↗MalfunctionSep 3, 2026Corroded; Crack
The customer returned the videoscope for a separate issue. During the initial evaluation of the device, it was observed that the plastic distal end cover, the bending section cover and its adhesive, objective lens, light guide lens, and insertion tube boot were corroded. The distal end's plastic cover was also chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591986 ↗MalfunctionSep 2, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572314 ↗MalfunctionSep 2, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570481 ↗MalfunctionSep 2, 2026Fracture; Material Fragmentation
The customer reported they were flushing their scope this morning, and the plastic tip broke off during reprocessing involving an Olympus Cysto-Nephro Videoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569895 ↗MalfunctionSep 2, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569575 ↗MalfunctionSep 2, 2026Loss of or Failure to Bond; Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566287 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
The customer reported a separate issue with the Cystonephrofiberscope. During the initial evaluation of the device, it was observed that the adhesive on the bending section was missing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531952 ↗MalfunctionAug 31, 2026Material Fragmentation; Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530999 ↗MalfunctionAug 27, 2026Corroded
The customer reported the Cysto-Nephro Videoscope had a separate issue. During the initial evaluation of the device it was observed, that the channel had corrosion inside, the objective lens had corrosion, and the bending section rubber had corrosion. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480476 ↗MalfunctionAug 20, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356463 ↗MalfunctionAug 20, 2026Material Separation; Material Deformation
The customer returned the Cysto Nephro Videoscope to the service center for a separate issue. During the device analysis, the service repair technician indicated the bending section cover/distal sheath was torn/detached and the insertion tube dented/bulging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50345577 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50313270 ↗MalfunctionAug 18, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308051 ↗MalfunctionAug 18, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50290628 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component; Failure to Clean Adequately
The customer returned the Cysto-Nephro Videoscope for a separate issue. During the initial evaluation of the device it was observed, chipped light guide lens glue and rust at the opening of the channel. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50290400 ↗MalfunctionAug 14, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50252058 ↗MalfunctionAug 13, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50239849 ↗MalfunctionAug 13, 2026Dent in Material; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236572 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229600 ↗
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-0689-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
- Z-0690-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
- Z-0692-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-V2R, VISERA Cysto-Nephro Videoscope
- Z-0331-2024 · Sep 25, 2023 · Open, ClassifiedCystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
Other Cystoscope And Accessories, Flexible/Rigid devices
- CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHOlympus Medical Systems Corp. · Cystoscope And Accessories, Flexible/Rigid2 recalls1 death1,380 reports
- CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHROlympus Medical Systems Corp. · Cystoscope And Accessories, Flexible/Rigid2 recalls377 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall353 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall1 death332 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid2 recalls75 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5ROlympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid114 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5ROlympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall54 reports
- HOPKINS 27293AAKarl Storz GmbH & Co. KG · Cystoscope and accessories, flexible/rigid2 recalls2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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