URETERO-RENO FIBERSCOPE OLYMPUS URF-P7 (UDI 04953170403811)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of URETERO-RENO FIBERSCOPE (6)
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 fiberscope is an endoscope. It has 199 adverse event reports, with no deaths, 16 injuries and 183 malfunctions. Most describe parts coming loose or breaking, such as chipped glue and detached adhesive, and cleaning problems. Reports rose to 102 in the last 12 months from 10 the year before. There is 1 open recall, started in September 2023, over a drying process that was not validated, which may leave water in the channel, raising infection risk.
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
- 206
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 04953170403811), received between Dec 1, 2020 and Sep 29, 2026 — classified as 16 injuries, 190 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
- Break21
- Failure to Clean Adequately19
- Microbial Contamination of Device19
- Adverse Event Without Identified Device or Use Problem12
- Material Fragmentation11
- Peeled/Delaminated10
- Contamination9
Patient problems
- No Clinical Signs, Symptoms or Conditions189
- Foreign Body In Patient3
- Hematuria3
- Fever2
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information2
- Obstruction/Occlusion2
- Unspecified Kidney or Urinary Problem2
Recent adverse event reports
The 25 most recent of 206 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Stretched
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939800 ↗MalfunctionSep 28, 2026Material Separation
The customer reported the flexible tip part that is attached to the body, its separated from the flexible part. You can't see the skeleton, but you can see that its broken. The observation occurred during reprocessing involving an Olympus Uretero-Reno Fiberscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913734 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906126 ↗MalfunctionSep 25, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903955 ↗MalfunctionSep 25, 2026Environmental Particulates
The customer reported that the Uretero-Reno Videoscope had a separate issue. During the initial evaluation of the device, it was observed that dirt was on the objective lens. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898427 ↗MalfunctionSep 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889761 ↗MalfunctionSep 4, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50621630 ↗MalfunctionSep 2, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563478 ↗MalfunctionSep 1, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547742 ↗MalfunctionSep 1, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542488 ↗MalfunctionAug 24, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421785 ↗MalfunctionAug 19, 2026Crack
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 A-rubber glue was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50325771 ↗MalfunctionAug 14, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50259627 ↗MalfunctionAug 11, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213028 ↗MalfunctionAug 11, 2026Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204482 ↗MalfunctionAug 6, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50159207 ↗MalfunctionAug 6, 2026Stretched
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158981 ↗MalfunctionAug 4, 2026Crack; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132219 ↗MalfunctionAug 4, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131735 ↗MalfunctionJul 21, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25888601 ↗MalfunctionJul 20, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE URETERO-RENO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SKELETONS ON THE BENDING SECTION WAS FOUND DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884435 ↗MalfunctionJul 20, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25882019 ↗MalfunctionJul 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25868285 ↗MalfunctionJul 17, 2026Peeled/Delaminated
THE CUSTOMER RETURNED THE URETERO-RENO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, IT WAS INDICATED THAT LIFTED PINS AT THE BENDING SECTION WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861595 ↗MalfunctionJul 15, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE URETERORENO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT RESIDUE ON THE OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25824254 ↗
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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