VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2 (UDI 04953170287091)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170287091), received between Feb 8, 2019 and Dec 13, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (2 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.

Recalls naming this device

1. Dec 4, 2023Class IIOpen, Classified

   Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

   Z-0691-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Misassembled; Misassembled

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD WIRE COMING OUT THE TIP. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925608 ↗
• MalfunctionOct 25, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE DISTAL END OF THE CHANNEL ON THE VIDEOSCOPE WAS STRIPPED DOWN TO METAL, AND IT IS SUSPECTED THAT THE ETHYLENE OXIDE (GAS) VALVE CAP WAS NOT PLACED ON THE UNIT DURING REPROCESSING. THE ISSUE OCCURRED DURING REPROCESSING. NO PATIENT INFECTIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536204 ↗
• MalfunctionJun 27, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE CYSTO-NEPHRO VIDEOSCOPE EXPERIENCED THE SCOPE WAS BLOWN DUE TO PRESSURE CAP NOT BEING ATTACHED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623776 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED BY THE USER FACILITY¿S PERFORMING DOCTOR THAT THE PATIENT EXPERIENCES AN ALLERGIC REACTION AFTER UNDERGOING REPEAT CYSTOSCOPY PROCEDURES. DUE TO A PRE-EXISTING CONDITION, THE PATIENT MUST UNDERGO A CYSTOSCOPY EVERY THREE MONTHS. THE PATIENT EXPERIENCES SWELLING OF THE PENIS AND PURPLE DISCOLORATION. THE PATIENT HAS NO PRE-EXISTING ALLERGIES. THE PATIENT WAS GIVEN TOPICAL CREAM TO TREAT THE REACTION. THE DOCTOR REPORTED THAT THE PATIENT¿S CONDITION LAST APPROXIMATELY TWO OR THREE WEEKS. THE DOCTOR REPORTED THAT ONLY KY LUBRICANT IS USED. THERE ARE NO OTHER LUBRICANTS, CREAMS, OR SOAPS USED DURING THE PROCEDURE. THIS PATIENT IS AN ISOLATED CASE, NO OTHER PATIENTS HAVE BEEN NOTED WITH THIS REACTION. IN ADDITION, THE USER FACILITY REPORTED THAT THEY ARE NOT 100% SURE THAT THIS IS RELATED TO THE SCOPE.

  Patient problems: Local Reaction

  MAUDE report 9507500 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED BY THE USER FACILITY¿S PERFORMING DOCTOR THAT THE PATIENT EXPERIENCES AN ALLERGIC REACTION AFTER UNDERGOING REPEAT CYSTOSCOPY PROCEDURES. DUE TO A PRE-EXISTING CONDITION, THE PATIENT MUST UNDERGO A CYSTOSCOPY EVERY THREE MONTHS. THE PATIENT EXPERIENCES SWELLING OF THE PENIS AND PURPLE DISCOLORATION. THE PATIENT HAS NO PRE-EXISTING ALLERGIES. THE PATIENT WAS GIVEN TOPICAL CREAM TO TREAT THE REACTION. THE DOCTOR REPORTED THAT THE PATIENT¿S CONDITION LAST APPROXIMATELY TWO OR THREE WEEKS. THE DOCTOR REPORTED THAT ONLY KY LUBRICANT IS USED. THERE ARE NO OTHER LUBRICANTS, CREAMS, OR SOAPS USED DURING THE PROCEDURE. THIS PATIENT IS AN ISOLATED CASE, NO OTHER PATIENTS HAVE BEEN NOTED WITH THIS REACTION. THE DOCTOR DID NOT KNOW THE SPECIFIC SERIAL NUMBER FOR THE REFERENCED SCOPE; THEREFORE, IT IS UNKNOWN IF THE SCOPE WAS RETURNED TO OLYMPUS FOR EVALUATION/SERVICE AND A REVIEW OF THE INSTRUMENT¿S HISTORY COULD NOT BE PERFORMED. THE SERVICE CENTER DID FOLLOW UP WITH THE USER FACILITY TO OBTAIN THE FOLLOWING ADDITIONAL INFORMATION: THE DISINFECTANT/SOLUTION USED TO REPROCESS THE SCOPE AND THE PATIENT¿S PROCEDURE DATE; HOWEVER, THIS INFORMATION WAS NOT PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Discoloration; Swelling

  MAUDE report 9507369 ↗
• InjuryFeb 8, 2019Mechanical Problem; Difficult to Remove; Mechanical Problem; Difficult to Remove

  OLYMPUS WAS INFORMED THAT DURING A PROCEDURE, A SCOPE BECAME STUCK INSIDE THE PATIENT¿S URETHRA. THE SCOPE¿S INSERTION TUBE WAS IN A 360 DEGREE LOOP AND THE UP LEVER WORKED BUT THE DOWN LEVER DID NOT MOVE THE BENDING SECTION TIP OF THE SCOPE. THE PHYSICIAN HAD DECIDED TO CUT THE SCOPE¿S INSERTION TUBE AND HAD TO RUSH THE PATIENT INTO SURGERY.

  Patient problems: Injury

  MAUDE report 8324293 ↗