CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHR (UDI 04953170310522)Recalls & reported problems
Olympus Medical Systems Corp. · CYF-VHR HD FlexCystoNephroVideoscope Rev · Class 2
All models of CYSTO-NEPHRO VIDEOSCOPE (7)
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 cysto-nephro videoscope has 123 adverse event reports, with no deaths and 23 injuries. Many reports describe parts detaching from the scope, while others describe splitting or peeling materials and cleaning that does not fully work. One open recall, started in December 2023, concerns updated instructions that no longer allow reusable cleaning brushes for manual cleaning. Reports rose from 26 in the previous year to 41 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
- 125
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 04953170310522), received between Oct 4, 2018 and Sep 4, 2026 — classified as 23 injuries, 102 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (46 reports).
1 FDA recall record name this device's 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, 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-0690-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component46
- Failure to Clean Adequately13
- Corroded8
- Device Reprocessing Problem8
- Material Split, Cut or Torn8
- Peeled/Delaminated8
- Break7
- Crack7
Patient problems
- No Clinical Signs, Symptoms or Conditions96
- Urinary Tract Infection14
- Unspecified Infection7
- Foreign Body In Patient2
- No Patient Involvement2
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600096 ↗MalfunctionSep 2, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573452 ↗MalfunctionSep 2, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570770 ↗MalfunctionAug 18, 2026Corroded; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50309045 ↗MalfunctionAug 13, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236356 ↗MalfunctionAug 11, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214525 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202304 ↗MalfunctionJul 20, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE CYSTO NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT AN ORANGE RESIDUE AFFECTING THE IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25880963 ↗MalfunctionJul 17, 2026Mechanical Jam; Positioning Problem
THE CUSTOMER RETURNED THE CYSTO-NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, IT WAS INDICATED THAT THERE WAS NO ANGULATION OR MOVEMENT WITH THE KNOB DUE TO A STIFF BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862232 ↗MalfunctionJul 15, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTO-NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT CHIPPED OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25830142 ↗MalfunctionJul 15, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTO-NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN FOUND THE DISTAL END TO BE DETACHED, LIKELY DUE TO STRESS. 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 25829829 ↗MalfunctionJul 14, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTO-NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT A DETACHED DISTAL END WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25819890 ↗MalfunctionJul 14, 2026Material Separation
THE CUSTOMER RETURNED THE CYSTO-NEPHRO VIDEOSCOPE, WHICH WAS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, A CHIP ON C-COVER WAS OBSERVED, LIKELY DUE TO STRESS. 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 25816437 ↗MalfunctionJul 7, 2026Loss of or Failure to Bond
THE CUSTOMER RETURNED THE CYSTO-NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN FOUND THE BENDING SECTION SHEATH ADHESIVE TO BE CHIPPED/DETACHED. THE ADHESIVE BOND 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 25733561 ↗MalfunctionJun 4, 2026Detachment of Device or Device Component
THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A DEFECTIVE CONTROLLER. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT, HOWEVER, A REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, A DETACHED BENDING SECTION WAS FOUND, LIKELY DUE TO STRESS. 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 25392494 ↗MalfunctionMay 28, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTO-NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A DETACHED BENDING SECTION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318251 ↗MalfunctionMay 27, 2026Crack; Material Fragmentation
THE CUSTOMER RETURNED THE CYSTO-NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE REPAIR CENTER REPRESENTATIVE INDICATED THAT A CHIPPED LIGHT GUIDE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25306513 ↗MalfunctionMay 21, 2026Peeled/Delaminated
THE CUSTOMER DID NOT REPORT A MALFUNCTION. DURING INSPECTION OF THE CYSTO-NEPHRO VIDEOSCOPE, PEELED BENDING SECTION COVER OR DISTAL SHEATH ADHESIVE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243499 ↗MalfunctionMay 20, 2026Loss of or Failure to Bond
THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF LEAK BETWEEN THE CONNECTORS AND THE CONTROLLER. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, ADHESIVE MISSING AT THE CHARGED COUPLE DEVICE LENS WAS FOUND TO BE MOST LIKELY DUE TO DEGRADATION PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225964 ↗MalfunctionMay 12, 2026Loss of or Failure to Bond
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED A CHIPPED LIGHT GUIDE LENS. NO PATIENT INJURY OCCURRED. IF THIS MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25156783 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A HOLE THAT WAS PUNCTURED AND BUBBLING. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, A DETACHED DISTAL END AND A CHIPPED BENDING SECTION COVER WAS FOUND TO BE MOST LIKELY DUE TO DEGRADATION AND STRESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25154102 ↗MalfunctionMay 7, 2026Break
THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF SCOPE CORD IS CUT, WILL NOT HOLD PRESSURE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE DETACHED DISTAL END IN THE BENDING SECTION WAS FOUND TO BE MOST LIKELY DUE TO A BREAK IN THE ADHESIVE DUE TO STRESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 25108632 ↗MalfunctionMay 4, 2026Detachment of Device or Device Component
THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF SEAL ON THE TIP IS BROKEN. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT, HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING INSPECTION AND TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE DISTAL END WAS DETACHED, MOST LIKELY DUE TO STRESS. 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 25073296 ↗MalfunctionApr 17, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE HAD A RUSTY OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915511 ↗MalfunctionApr 16, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED LIFTING A-RUBBER GLUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899413 ↗
Other Endoscope, accessories, narrow band spectrum devices
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- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- 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 · 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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