URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3R (UDI 04953170403392)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 ureteroreno videoscope is a flexible camera used inside the urinary tract. Many of the 180 reports describe parts coming loose, corrosion and breaks. The reports include 170 malfunctions, 10 injuries and no deaths. Reports from the last 12 months number 132, up from 26 in the 12 months before. One recall, started in September 2023 and still open, concerns scopes returned after repair with water left in their channels, which could lead to infection.
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
- 182
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 04953170403392), received between Dec 27, 2019 and Sep 30, 2026 — classified as 10 injuries, 172 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (43 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 Component43
- Corroded22
- Break16
- Failure to Clean Adequately13
- Degraded12
- Material Split, Cut or Torn10
- Mechanical Jam10
- Device Reprocessing Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions172
- Foreign Body In Patient2
- Unspecified Tissue Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- Laceration(s)1
- No Patient Involvement1
- Physical Entrapment1
Recent adverse event reports
The 25 most recent of 182 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Corroded
The customer returned the Uretero Reno Videoscope for a separate issue. No patient involvement. During the initial evaluation of the device, it was observed that the bending section, the rotation mechanism, the control body and the scope connector adhesive had corrosion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941881 ↗MalfunctionSep 28, 2026Corroded
The customer returned the Uretero-Reno Videoscope for a separate issue. During inspection of the device, the service repair technician indicates that there was corrosion in the bending section. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915610 ↗MalfunctionSep 25, 2026Positioning Failure; Physical Resistance/Sticking
The customer reported that the Uretero-Reno Videoscope had a separate issue. During the initial evaluation of the device, it was observed that the control knob angulation lever was stuck at the neutral position. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900337 ↗MalfunctionSep 25, 2026Corroded; Positioning Problem
The customer reported the Uretero-Reno Videoscope had a separate issue. During the initial evaluation of the device it was observed, that distal end plastic cover and the objective lens had corrosion, and the control knob was stuck, no movement. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898382 ↗MalfunctionSep 4, 2026Degraded
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50621080 ↗MalfunctionSep 4, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50615525 ↗MalfunctionAug 27, 2026Mechanical Jam
The customer returned the Endoeye Flex Deflectable Videoscope for a separate issue. During the initial evaluation of the device it was observed that there was zero movement on the control knob. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478473 ↗MalfunctionAug 13, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238821 ↗MalfunctionAug 12, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223304 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221673 ↗MalfunctionAug 12, 2026Material Fragmentation
The customer returned the Uretero-Reno Videoscope to the service center for a separate issue. During the device analysis, it was indicated that the bending section cover adhesive and C-cover was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221007 ↗MalfunctionJul 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065045 ↗MalfunctionJul 27, 2026Positioning Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046630 ↗MalfunctionJul 27, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50036892 ↗MalfunctionJul 21, 2026Material Fragmentation
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CHIPPED ADHESIVE AT THE BENDING RUBBER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT. ¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884718 ↗MalfunctionJul 20, 2026Degraded
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, IT WAS INDICATED THAT A CHIPPED GLUE AT THE BENDING SECTION COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25882921 ↗MalfunctionJul 15, 2026Loss of or Failure to Bond
THE CUSTOMER RETURNED THE URETERO-RENO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THE BENDING SECTION COVER/DISTAL SHEATH GLUE WAS LIFTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25829728 ↗MalfunctionJul 13, 2026Detachment of Device or Device Component
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 THERE IS MISSING BENDING SECTION COVER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25803648 ↗MalfunctionJul 7, 2026Loss of or Failure to Bond
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, IT WAS INDICATED THAT A PEELED BENDING SECTION COVER ADHESIVE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25738885 ↗MalfunctionJul 7, 2026Material Fragmentation
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CHIPPED ADHESIVE ON THE BENDING SECTION COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25737979 ↗MalfunctionJun 30, 2026Detachment of Device or Device Component
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 A CHIP ON THE A-RUBBER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668589 ↗MalfunctionJun 25, 2026Degraded
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, ADHESIVE WAS CHIPPED AND LIFTED AT THE BENDING SECTION. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE WAS DUE TO STRESS PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25631176 ↗MalfunctionJun 25, 2026Peeled/Delaminated
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE ADHESIVE WAS DETACHED AT THE BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25631139 ↗MalfunctionJun 23, 2026Material Split, Cut or Torn
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CHIPPED A-RUBBER ADHESIVE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25602052 ↗MalfunctionJun 22, 2026Break
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CHIPPED BENDING SECTION ADHESIVE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT. ¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25586478 ↗
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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