URETERO-RENO FIBERSCOPE OLYMPUS URF-P7R (UDI 04953170403835)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 has 122 adverse event reports, with no deaths and 2 injuries. Many reports describe parts detaching or peeling, poor cleaning, and degraded or fragmented parts, often found when scopes were returned for service. Reports rose from 15 in the previous year to 95 in the latest year. One open recall, started in September 2023, concerns channels that may stay wet after repair and 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
- 121
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 04953170403835), received between Aug 2, 2019 and Aug 19, 2026 — classified as 2 injuries, 119 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (29 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 Component29
- Failure to Clean Adequately14
- Peeled/Delaminated12
- Degraded11
- Material Fragmentation8
- Device Reprocessing Problem6
- Break5
- Crack5
Patient problems
- No Clinical Signs, Symptoms or Conditions118
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324186 ↗MalfunctionAug 18, 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, it was indicated that a missing bending section glue was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50290296 ↗MalfunctionAug 14, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256636 ↗MalfunctionAug 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253718 ↗MalfunctionAug 13, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235462 ↗MalfunctionAug 13, 2026Material Deformation
The customer returned the uretero-reno fiberscope to the service center for a separate issue. During the device analysis, the service repair technician indicated that an excessively stretched bending rubber was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230665 ↗MalfunctionAug 11, 2026Degraded; Stretched
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216319 ↗MalfunctionAug 11, 2026Crack; Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50203814 ↗MalfunctionAug 7, 2026Stretched
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177937 ↗MalfunctionAug 6, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158350 ↗MalfunctionAug 4, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130060 ↗MalfunctionAug 4, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129102 ↗MalfunctionJul 28, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50049112 ↗MalfunctionJul 27, 2026Corroded; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034817 ↗MalfunctionJul 27, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50027686 ↗MalfunctionJul 21, 2026Environmental Particulates
THE CUSTOMER RETURNED THE URETERO-RENO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE OBJECTIVE LENS WAS FOUND DIRTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884782 ↗MalfunctionJul 17, 2026Detachment of Device or Device Component; Material Deformation
THE CUSTOMER RETURNED THE URETERORENO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CHIPPED BENDING SECTION COVER AND BUNCHED UP A-RUBBER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861684 ↗MalfunctionJul 10, 2026Detachment of Device or Device Component
THE URETERO-RENO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A LINE IN THE MIDDLE OF THE SCOPE. 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 BENDING SECTION COVER ADHESIVE WAS LIFTED AND WAS FOUND TO BE MOST LIKELY DUE TO DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25780189 ↗MalfunctionJun 26, 2026Peeled/Delaminated
THE CUSTOMER RETURNED THE URETERO-RENO FIBERSCOPE TO THE SERVICE CENTER FOR POOR QUALITY IMAGE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE EVENT WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE ADHESIVE PEELING AT THE BENDING SECTION WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641683 ↗MalfunctionJun 25, 2026Material Separation
THE CUSTOMER RETURNED THE URETERO-RENO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT THE BENDING SECTION COVER GLUE WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621317 ↗MalfunctionJun 23, 2026Break
THE CUSTOMER RETURNED THE URETERO-RENO FIBERSCOPE 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 25596474 ↗MalfunctionJun 23, 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 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 25596275 ↗MalfunctionJun 18, 2026Peeled/Delaminated
THE CUSTOMER RETURNED THE URETERO-RENO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT BENDING SECTION COVER GLUE PEELED AT DISTAL END WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25555801 ↗MalfunctionJun 11, 2026Material Fragmentation
THE CUSTOMER RETURNED THE URETERO-RENO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT THE BENDING SECTION COVER GLUE HAS CHIPPED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25470264 ↗MalfunctionJun 8, 2026Crack
THE VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A LEAK AND BROKEN TIP. 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 OBJECTIVE LENS WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25437629 ↗
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 VIDEOSCOPE OLYMPUS URF-V2ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall305 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
- 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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