VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2R (UDI 04953170287619)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170287619), received between Feb 6, 2019 and Mar 17, 2025 — classified as 1 injury, 3 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Failure to Clean Adequately; Failure to Clean Adequately

  AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) HAS BEEN DISPATCHED TO OBSERVE THE USER FACILITY¿S REPROCESSING PRACTICES FROM START TO FINISH AND PROVIDE A REPROCESSING IN-SERVICE TRAINING, IF NECESSARY, TO CORRECT AND ADDRESS ANY REPROCESSING DEVIATIONS. WHILE ESS WAS ONSITE WITH THE CUSTOMER AT THE FACILITY THE CUSTOMER STATED THEY HAVE BEEN USING THE SAME RINSE WATER ALL DAY. THE ISSUE WAS OBSERVED DURING REPROCESSING, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627420 ↗
• MalfunctionJun 26, 2020Break; Break

  THE USER FACILITY REPORTED THAT PARTS FALL OFF FROM THE DISTAL END OF THE SCOPE. THE SCOPE HAS A HOLE, AND THE ETO CAP WAS BROKEN.

  Patient problems: No Patient Involvement

  MAUDE report 10201296 ↗
• MalfunctionJun 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY RETURNED THE DEVICE FOR EVALUATION AND SERVICE DUE TO THE AIR/WATER LEAKAGE OR FLUID INVASION ISSUE. IT WAS ALSO REPORTED THAT THE BENDING SECTION SHEATH OF THE BENDING SECTION BURST OUT, AS THE DEVICE WAS STERILIZED WITHOUT ATTACHING THE SAFETY CAP. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION AND WAS INFORMED THAT THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10153099 ↗
• InjuryFeb 6, 2019Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS WAS INFORMED THAT A PATIENT TESTED (B)(6) FOR AN UNSPECIFIED INFECTION AFTER UNDERGOING A PROCEDURE. THE PATIENT REPORTEDLY CAME IN WITH A FEVER. THE SCOPE WAS THEN TESTED AND CULTURED (B)(6) FOR AN UNSPECIFIED ORGANISM AFTER REPROCESSING.

  Patient problems: Unspecified Infection

  MAUDE report 8313576 ↗