MAMBA VISION 7315006Recalls & reported problems
Richard Wolf GmbH · SENSOR-CYSTOSCOPE 16.2FR WL 400MM flexible, working channel 7,5FR, slanted distal tip, TL 660mm, deflection +210°/-210°, two function buttons, control lever to distal – upward DEF, for connection to ENDOCAM Logic HD and ENDOCAM Logic HD lite 5525, LED-illumination, distal Sensor, Fixfocus · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207063477), received between Feb 16, 2023 and Jul 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Optical Distortion” (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 Distortion1
- Optical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT AT THE BEGINNING OF THE SURGICAL PROCEDURE THE DISTAL LIGHT OF THE CYSTOSCOPE FAILED. THE TREATMENT WAS UNABLE TO BE COMPLETED AND HAD TO BE CANCELLED. THERE IS NO REPORT OF INJURIES TO THE PATIENT OR OTHER THIRD PARTIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579645 ↗MalfunctionFeb 16, 2023Optical Distortion; Optical Distortion
THE USER REPORTED THE FOLLOWING: THE SCOPE IS DEAD (AFTER A FEW USES). USER CANCELLED THE CYSTOSCOPY, NO FUNCTION ON THE CYSTOSCOPE. USER HAS TO PLAN A NEW DATE FOR CYSTOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16387647 ↗
Other Cystoscope and accessories, flexible/rigid devices
- CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHOlympus Medical Systems Corp. · Cystoscope And Accessories, Flexible/Rigid2 recalls1 death1,380 reports
- CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHROlympus Medical Systems Corp. · Cystoscope And Accessories, Flexible/Rigid2 recalls377 reports
- VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2Olympus Medical Systems Corp. · Cystoscope And Accessories, Flexible/Rigid1 recall418 reports
- 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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