URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2RRecalls & reported problems
Olympus Medical Systems Corp. · "URF-V2R SLIM FLEX VID URETERO SCOPE, REV" · 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 is a flexible scope for the urinary tract. Many of the 304 reports describe parts detaching, breaking, or peeling, and the reports include 8 injuries and no deaths. There is 1 open recall, started in September 2023, over water left in the scope's channel after repair that could lead to infection. Reports rose from 37 in the prior 12 months to 208 in the most recent 12 months.
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
- 305
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 305 adverse event reports that list this exact device (DI 04953170343612), received between May 10, 2018 and Sep 25, 2026 — classified as 8 injuries, 297 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (71 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 Component71
- Break44
- Peeled/Delaminated36
- Material Deformation27
- Failure to Clean Adequately18
- Corroded17
- Material Split, Cut or Torn17
- Material Separation14
Patient problems
- No Clinical Signs, Symptoms or Conditions292
- Foreign Body In Patient4
- Unspecified Kidney or Urinary Problem4
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- Fever1
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 305 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Corroded; Degraded
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 corrosion on the objective lens and distal end. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896938 ↗MalfunctionSep 23, 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 was found to be chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868384 ↗MalfunctionSep 4, 2026Material Fragmentation; Peeled/Delaminated; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50622071 ↗MalfunctionSep 4, 2026Fracture
The customer reported the Uretero-Reno Videoscope had a separate issue. During the initial evaluation of the device it was observed, that the adhesive on the bending section rubber was chipped. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50614492 ↗MalfunctionSep 2, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565519 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50309881 ↗MalfunctionAug 14, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246793 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225990 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221264 ↗MalfunctionAug 10, 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 was found to be chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50193969 ↗MalfunctionAug 4, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130008 ↗MalfunctionJul 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074856 ↗MalfunctionJul 27, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022326 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50020237 ↗MalfunctionJul 27, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50008885 ↗MalfunctionJul 27, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50006068 ↗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 INDICATES THAT A CHIP ON RUBBER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25888608 ↗MalfunctionJul 17, 2026Crack
THE VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A LEAK. 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, IT WAS FOUND THAT THE BENDING SECTION COVER'S ADHESIVE WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862236 ↗MalfunctionJul 17, 2026Corroded; Detachment of Device or Device Component
THE CUSTOMER RETURNED THE URETERORENO VIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, RUST ON THE DISTAL END COVER AND A CHIPPED BENDING SECTION COVER ADHESIVE WERE OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25855701 ↗MalfunctionJul 16, 2026Detachment of Device or Device Component
THE CUSTOMER DID NOT REPORT A MALFUNCTION. DURING INSPECTION OF URETERO-RENO VIDEOSCOPE, MISSING BENDING SECTION COVER AND CHIPPED BENDING SECTION COVER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25849486 ↗MalfunctionJul 15, 2026Material Protrusion/Extrusion
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, IT WAS INDICATED THAT THE PIN ON THE BENDING SECTION WAS LIFTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25830020 ↗MalfunctionJul 9, 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 THE ADHESIVE ON THE DISTAL SHEATH WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765642 ↗MalfunctionJul 7, 2026Corroded
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED CORROSION ON DISTAL END PLASTIC COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25735418 ↗MalfunctionJul 2, 2026Component Missing; Detachment of Device or Device Component
THE URETERO-RENO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF SCOPE TIP DAMAGED. 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 RUBBER WAS FOUND TO BE MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698689 ↗MalfunctionJun 26, 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 INDICATED THAT IT WAS FOUND THE BENDING SECTION COVER GLUE WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637134 ↗
Other Ureteroscope and accessories, flexible/rigid devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall1,125 reports
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls397 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls190 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls170 reports
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3DOlympus Medical Systems Corp. · Ureteroscope And Accessories, Flexible/Rigid186 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall121 reports
- n.a. 091279-01Karl Storz GmbH & Co. KG · Ureteroscope and accessories, flexible/rigid118 reports
- Flex-X / IMAGE 1 S 11278VSUAKarl Storz GmbH & Co. KG · Ureteroscope 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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