F88 0502388100Recalls & reported problems
Sg Endoscopy Pte. Ltd. · Flexible Ureteroscope, Standard Deflection · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08881300750084), received between Sep 29, 2025 and Sep 29, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2025Break; No Display/Image; Break; No Display/Image
IT WAS REPORTED THAT THE IMAGE WAS LOST DURING THE PROCEDURE WHICH CONTRIBUTED TO THE PROCEDURE NOT BEING ABLE TO BE COMPLETED AND HAVING TO BE RESCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23174865 ↗
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
- 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
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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page