HOPKINS 27035BBRecalls & reported problems
Karl Storz GmbH & Co. KG · Universal-Cysto-Urethroscope, 20 Fr. · Class 2
All models of HOPKINS (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551232484), received between Jan 31, 2025 and Jan 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Optical Problem” (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
- Optical Problem1
- Solder Joint Fracture1
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.
MalfunctionJan 31, 2025Solder Joint Fracture; Optical Problem; Solder Joint Fracture; Optical Problem
IT WAS REPORTED THAT THE TELESCOPE PRESENTS LEAKS AT THE LENS TIP AND THE IMAGE BECAME BLURRY. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT, USER OR THIRD. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21287056 ↗
Other Cystoscope and accessories, flexible/rigid devices
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- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall353 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall1 death332 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid2 recalls75 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5ROlympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid114 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5ROlympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall54 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.
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