URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3 (UDI 04953170403385)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of URETERO-RENO 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 Uretero-Reno videoscope has 322 reports, including 5 injuries and no deaths. Many describe parts detaching, breaking or corroding, and cleaning that does not fully work. It has 1 recall, still open since September 2023, over scopes returned after repair with water left in their channels, which could lead to infection. Reports rose to 146 in the last 12 months from 33 in the 12 months before.
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
- 330
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 330 adverse event reports that list this exact device (DI 04953170403385), received between Jun 7, 2019 and Sep 30, 2026 — classified as 5 injuries, 325 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (42 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
- 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-0348-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component42
- Break38
- Failure to Clean Adequately38
- Corroded31
- Microbial Contamination of Device23
- Mechanical Problem21
- Device Reprocessing Problem17
- Material Split, Cut or Torn17
Patient problems
- No Clinical Signs, Symptoms or Conditions319
- No Patient Involvement4
- Laceration(s)2
- No Consequences Or Impact To Patient2
- Discomfort1
- Obstruction/Occlusion1
- Perforation1
- Renal Failure1
Recent adverse event reports
The 25 most recent of 330 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Contamination /Decontamination Problem
The customer did not report a malfunction. During inspection of the Uretero-Reno Videoscope, the service repair technician indicated that there was foreign material inside the device. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948748 ↗MalfunctionSep 30, 2026Corroded
The customer returned the Uretero-Reno Videoscope to the service center for evaluation related to a separate issue. During testing, the service repair technician identified the device had light guide lens, objective lens, and distal end corrosion. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947978 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
The customer reported the Uretero-Reno Videoscope's port had come out of place during reprocessing. During the initial evaluation of the device, it was confirmed that the biopsy port was pulled out. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935219 ↗MalfunctionSep 28, 2026Stretched
The customer returned the Uretero-Reno Fiberscope to the service center for evaluation related to a separate issue. During testing, the service repair technician identified the A-rubber was stretched/bulging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917013 ↗MalfunctionSep 25, 2026Degraded
:The customer returned the Uretero-Reno Fiberscope to the service center for evaluation related to a separate issue. During pre-investigation/equipment intake, the service repair technician identified A-rubber glue was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899321 ↗MalfunctionSep 25, 2026Device Reprocessing Problem
During onsite inspection of Uretero-Reno Videoscope, it was found the objective lens was dirty. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898201 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862898 ↗MalfunctionSep 21, 2026Detachment of Device or Device Component
The customer returned the Uretero-Reno Videoscope for a separate issue. During inspection of the device, the service repair technician indicates that the a-rubber glue is chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842343 ↗MalfunctionSep 4, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616676 ↗MalfunctionSep 4, 2026Residue After Decontamination; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50614071 ↗MalfunctionSep 3, 2026Loss of or Failure to Bond; Detachment of Device or Device Component
The customer returned the URETERO-RENO VIDEOSCOPE to the service center for a separate issue. During the device initial analysis, the service repair team noted that the adhesive on the device A-Rubber bending section was found to be peeled and needed to be replaced.There was no patient involvement in this reported event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589529 ↗MalfunctionAug 21, 2026Detachment of Device or Device Component; Material Deformation
The customer returned the Uretero-Reno Videoscope to the service center for evaluation related to a separate issue. During testing, the service technician identified the device had detached distal end adhesive and bending section adhesive bulging, increased diameter. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50373887 ↗MalfunctionAug 20, 2026Corroded
The customer returned the Uretero-Reno Videoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates that the distal end plastic cover is corroded. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50346585 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50329595 ↗MalfunctionAug 18, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311578 ↗MalfunctionAug 17, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279380 ↗MalfunctionAug 13, 2026Physical Resistance/Sticking
The customer reported that it was observed that the control knob was stuck and could not flex. The malfunction was found during an unspecified procedure. The procedure was completed with a backup device. The issue involved an Olympus uretero-reno videoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230938 ↗MalfunctionAug 13, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230373 ↗MalfunctionAug 12, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223970 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211830 ↗MalfunctionAug 11, 2026Material Fragmentation
The customer reported that Uretero-Reno Videoscope had a separate issue. During the initial evaluation of the device, it was observed that the bending section rubber glue was found chipped. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201589 ↗MalfunctionAug 4, 2026Peeled/Delaminated; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128331 ↗MalfunctionJul 27, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50036771 ↗MalfunctionJul 27, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022382 ↗MalfunctionJul 15, 2026Material Deformation
THE CUSTOMER REPORTED THE URETERO-RENO VIDEOSCOPE BENDING RUBBER WAS BUNCHED UP, THE ISSUE WAS OBSERVED DURING DEVICE REPROCESSING, AND THE CAUSE OF THE ISSUE IS UNKNOWN. 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 25831626 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- 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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