VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF- TYPE VA2 (UDI 04953170339455)Recalls & reported problems
Olympus Medical Systems Corp. · CYF-VA2 Flex CystoNephro Videoscope wAsp · Class 2
All models of VISERA CYSTO-NEPHRO VIDEOSCOPE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Visera CystoNephro videoscope is a thin flexible scope used to look inside the bladder and kidneys. Many of the 162 reports describe scopes that are not cleaned adequately, cover pieces coming loose, and foreign material inside the instrument channel, and some mention urinary tract infections. The reports include no deaths and 16 injuries. No recalls name this device.
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
- 162
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 04953170339455), received between Jan 7, 2022 and Aug 4, 2025 — classified as 16 injuries, 146 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (48 reports).
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
Most reported problems
Device problems
- Failure to Clean Adequately48
- Scratched Material19
- Device Reprocessing Problem18
- Detachment of Device or Device Component13
- Contamination11
- Material Split, Cut or Torn9
- Loose or Intermittent Connection8
- Mechanical Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions146
- Urinary Tract Infection13
- Chills5
- Fever5
- Pain5
- Urinary Frequency / Polyuria5
- Bacterial Infection2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE VIDEOSCOPE'S BENDING SECTION COVER'S ADHESIVE WAS DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22703272 ↗MalfunctionAug 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE VIDEOSCOPE EXHIBITED A DETACHED BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22691690 ↗MalfunctionJun 10, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT AFTER CLEANING AND USING THE CYSTO-NEPHRO VIDEOSCOPE, SOMETHING, LOOKED LIKE A PART, WAS LEFT IN THE REPROCESSING CLEANING TUB. THE EVENT OCCURRED DURING REPROCESSING OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177159 ↗MalfunctionMay 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE VIDEOSCOPE EXHIBITED THE RUBBER BENDING SECTION COVER WAS CUT OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22090918 ↗MalfunctionNov 26, 2024Material Deformation; Material Deformation
IT WAS REPORTED, THE SUBJECT DEVICE TIP HAD COME UNDONE, EXPOSING THE MECHANISM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20782237 ↗MalfunctionNov 14, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20689327 ↗MalfunctionNov 13, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, THE CYSTO-NEPHRO VIDEOSCOPE HAD A COMPROMISED IMAGE. THE ISSUE OCCURRED, DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20675969 ↗MalfunctionNov 7, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CYSTO NEPHRO VIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20634582 ↗MalfunctionNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE NEPHRO-VIDEOSCOPE'S FORCEPS CHANNEL PORT WAS NOT SECURED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20597493 ↗MalfunctionOct 30, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE VIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE RUBBER OF SWITCHES 1 AND 4. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569791 ↗MalfunctionOct 24, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED FOREIGN MATERIALS IN THE FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20526309 ↗MalfunctionOct 24, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED FOREIGN MATERIALS IN THE FORCEPS CHANNEL AND A-RUBBER (BENDING SECTION COVER). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20525178 ↗MalfunctionOct 21, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A LOOSE FITTING OF THE FORCEPS STOPPER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20501087 ↗MalfunctionOct 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THERE WAS FOREIGN MATERIAL ON THE BENDING SECTION COVER OF THE CYSTO-NEPHRO VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20462474 ↗MalfunctionOct 15, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE FOLLOWING: BENDING SECTION COVER AND ADHESIVE OF THE BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20457455 ↗MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED, THE CYSTO-NEPHRO VIDEOSCOPE WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20457050 ↗MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE CYSTO-NEPHRO VIDEOSCOPE WAS INCORRECTLY REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433525 ↗MalfunctionOct 11, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THAT THE CYSTO-NEPHRO VIDEOSCOPE HAS BEEN REPROCESSED MANUALLY IN THE SINK, THEN PLACED INTO AN AUTOMATIC ENDOSCOPE REPROCESSOR AND THEN INTO A TYVEK POUCH TO BE PLACED INTO THE STERRAD MACHINE FOR STERILIZATION. THE SCOPE WAS COMPLETELY DRY ENTERING THE POUCH AND SAME WHEN REMOVED FROM THE MACHINE. THE SCOPE WAS STORED IN THESE POUCHES UNTIL USE. THE POUCH ITSELF APPEARED TO STICK TO THE OUTER LAYER ON THE SCOPE AND WHEN REMOVED FROM THIS POUCH CAN LEAVE A STICKY GLUE RESIDUE AND ALSO REMOVE RUBBER FROM THE SCOPE. THE EVENT OCCURRED DURING REPROCESSING. THE PROCEDURE WAS UNKNOWN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427711 ↗MalfunctionOct 8, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED THE COATING ON THE TIP PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20400923 ↗MalfunctionOct 8, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION THAT FOREIGN MATERIAL WAS FOUND ON THE ANGLE LEVER OF THE CONTROL BODY, FE LEVER OF THE CONTROL BODY, SOFT TUBE AT THE INSERTION SITE, CONTROL BODY, AND UP/DOWN PLATE OF THE CONTROL BODY ON THE VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20394007 ↗MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CYSTO-NEPHRO VIDEOSCOPE'S FORCEPS PLUG NOZZLE WAS LOOSE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392550 ↗MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE VIDEOSCOPE FORCEPS PORT WAS BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20303688 ↗MalfunctionSep 24, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, FOREIGN MATERIAL WAS INSIDE THE CONTROL BODY OF THE CYSTO-NEPHRO VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20292328 ↗MalfunctionSep 19, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE CYSTO-NEPHRO VIDEOSCOPE'S PART OF THE TIP OF THE CONNECTION CONNECTOR CAME OFF AND REMAINED IN THE CLEANING MACHINE CONNECTION PORT. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20263593 ↗MalfunctionSep 16, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THE VISERA CYSTO-NEPHRO VIDEOSCOPE HAD BROWN WATER WITH FOREIGN MATERIAL COME OUT OF THE DEVICE, WHEN WATER WAS PASSSED THROUGH THE FORCEPS CHANNEL. THE ISSUE OCCURRED AFTER REPROCESSING. THE DEVICE HAD BEEN USED IN A DIAGNOSTIC BLADDER AND URETHRA EXAMINATION BEFORE BEING REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20223865 ↗
Other Endoscope, accessories, narrow band spectrum devices
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- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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
- 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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