CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHA (UDI 04953170310508)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04953170310508), received between Oct 26, 2021 and May 20, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Corroded” (5 reports).

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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Corroded

  THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF LEAKAGE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, CORRODED OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230871 ↗
• MalfunctionMay 20, 2026Device Reprocessing Problem

  THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF ANGLES OUT OF RANGE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE CONTROL UNIT WAS DIRTY, WAS FOUND TO BE MOST LIKELY DUE TO WATER LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230587 ↗
• MalfunctionMay 12, 2026Contamination /Decontamination Problem

  THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS. THUS, INVESTIGATION WAS CONDUCTED BASED ON NEW COMPLAINT INFORMATION WHICH STATES THAT THE CYSTO-NEPHRO VIDEOSCOPE WAS REPROCESSED USING OER-4 WITH THE FOREIGN MATERIAL RESIDUE. THERE WAS NO REPORT RELATED TO THE POSSIBILITY OF MICROBIAL CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152519 ↗
• MalfunctionApr 22, 2026Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE'S LIGHT GUIDE LENS CONTAINED CORROSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955854 ↗
• MalfunctionApr 17, 2026Corroded; Unstable

  THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF LOSS OF AIRTIGHTNESS. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, IT WAS FOUND THAT THE JOINT BETWEEN THE CURVED SECTION AND DISTAL END WAS NOT FIXED. IN ADDITION, IT WAS FOUND THAT THE OBJECTIVE LENS HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916797 ↗
• MalfunctionMar 5, 2026Material Fragmentation

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED THE LIGHT GUIDE LENS WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519972 ↗
• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THAT THE CYSTO-NEPHRO VIDEOSCOPE BENDING SECTION IS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432880 ↗
• MalfunctionDec 6, 2024Degraded; Degraded

  IT WAS REPORTED THAT DURING REPROCESSING THE SUBJECT DEVICE HAD COATING PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868681 ↗
• MalfunctionDec 20, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE CYSTO-NEPHRO VIDEOSCOPE, HAD A LEAK IN WORKING CHANNEL. THE ISSUE OCCURRED DURING REPROCESSING. THE PROCEDURE WAS UNKNOWN. THERE ARE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS AND THE EVALUATION FOUND THAT THE ADHESIVE AROUND OBJECTIVE LENS HAS FOREIGN OBJECTS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365609 ↗
• MalfunctionDec 19, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE VIDEOSCOPE HAD NO PICTURE FROM THE SCOPE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING WAS FOUND: THE ADHESIVE AROUND THE OBJECTIVE LENS HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359485 ↗
• MalfunctionDec 14, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE CYSTO-NEPHRO VIDEOSCOPE, IMAGE TURNS 60 DEGREES. THE ISSUE OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS UNKNOWN. THERE ARE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS AND THE EVALUATION FOUND THAT THE OBJECTIVE LENS HAD FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327136 ↗
• MalfunctionDec 8, 2023Disconnection; Disconnection

  THE CUSTOMER REPORTED TO OLYMPUS, THE CYSTO-NEPHRO VIDEOSCOPE HAD CONTROL PANEL CORROSION AND INTERNAL CORROSION. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND; THE FORCEPS CHANNEL PORT WAS DISCONNECTED. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18295543 ↗
• MalfunctionNov 2, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE CYSTO-NEPHRO VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054848 ↗
• MalfunctionOct 4, 2023Device Reprocessing Problem; Device Reprocessing Problem

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, WHEN CLEANING WITH AN OLYMPUS ENDOSCOPE REPROCESSOR, IT BECAME CLOUDY WHEN ENDOQUIK WAS ADDED. IT WAS DISCOVERED THAT THE ENDOQUIK HAD EXPIRED SIX MONTHS EARLIER. THE DEVICE THAT WAS BEING PROCESSED AT THE TIME WAS A CYSTO-NEPHRO VIDEOSCOPE. THE SUBJECT DEVICE WAS NOT USED FOR CASES WHEN IT BECAME CLOUDY, BUT THE ENDOQUIK WAS USED FOR REPROCESSING WITHIN THE PAST SIX MONTHS. IT IS UNKNOWN THE NUMBER OF CASES. THE CYSTO-NEPHRO VIDEOSCOPE IS CURRENTLY BEING REPROCESSED USING A NEW ENDOQUIK. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870160 ↗
• MalfunctionSep 11, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CYSTO-NEPHRO VIDEOSCOPE'S TIP INSERTION SECTION (UP TO CURVED SECTION) AND FORCEPS CHANNEL TESTED POSITIVE FOR TWICE FOR UNEXPECTED CONTAMINATION OF GRAM POSITIVE COCCI AND STAPHYLOCOCCI (STAPHYLOCOCCUS SPP.). THE SCOPE WAS RETESTED 4 DAYS LATER AND WAS NEGATIVE. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSONS TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719496 ↗
• MalfunctionAug 29, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE CYSTO-NEPHRO VIDEOSCOPE WAS ASSOCIATED WITH A RELATED COMPLAINT REPORTING THAT THE OER-6 REPROCESSOR UNIT COULD NOT DRAIN WATER SUFFICIENTLY WHEN REPLACING THE WATER FILTER. THE CUSTOMER FURTHER REPORTED THAT THIS SAME ISSUE OCCURRED IN A TOTAL OF 17 OER-6 UNITS AT THE FACILITY. DURING A FOLLOW UP, THE CUSTOMER WAS ASKED HOW OFTEN THE WATER FILTER WAS REPLACED AND THE CUSTOMER CONFIRMED NOT EVERY MONTH BUT RATHER EVERY HALF A YEAR. THE REPORTED ISSUE WAS DISCOVERED DURING REPROCESSING OF THE SCOPE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED BECAUSE IT WAS DETERMINED THAT THE SCOPE WAS REPROCESSED WITH AN OER-6 REPROCESSOR IN WHICH THE FILTER WAS NOT PLACED AT THE RECOMMENDED REPLACEMENT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643104 ↗
• MalfunctionAug 3, 2023Scratched Material; Scratched Material

  THE CUSTOMER ORIGINALLY RETURNED HIS OLYMPUS CYSTO-NEPHRO VIDEOSCOPE DUE TO AN ANGULATION ISSUE. ACCORDING TO THE INITIAL REPORTER, THE ANGULATION LOCK WAS NOT FUNCTIONING PROPERLY, AND THE UNIT HAD INSUFFICIENT ANGULATION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE FORCEPS STOPPER CAP HAD SCRAPPING PRESENT. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE DAMAGE FOUND DURING THE DEVICE EVALUATION ON THE FORCEPS STOPPER CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450203 ↗
• MalfunctionMay 11, 2023Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE HAD FOREIGN MATTER FALLING FROM THE CHANNEL. IT IS UNKNOWN WHEN THE REPORTED ISSUE WAS FOUND. THE REPORTABLE MALFUNCTIONS WERE DISCOVERED BY OLYMPUS STAFF DURING EVALUATION OF THE RETURNED DEVICE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916605 ↗
• MalfunctionFeb 16, 2023Mechanical Jam; Mechanical Jam

  INFORMATION OBTAINED IDENTIFIES THE DEVICE INSPECTED PRIOR TO USE, AND WAS RETURNED AFTER THE CYSTOSCOPY PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384818 ↗
• MalfunctionJan 18, 2023Corroded; Mechanical Problem; Corroded; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER WHICH CONFIRMED THE REPORTED EVENT OCCURRED DURING PREPARATION FOR USE OF AN UNKNOWN DIAGNOSTIC PROCEDURE. THERE WAS NO DELAY TO THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16198741 ↗
• MalfunctionDec 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS EMPLOYEE REPORTED DIRECTION OF THE BASE IS REVERSED (UP AND DOWN) OF A PRODUCT RETURN ASSET, CYSTO-NEPHRO VIDEOSCOPE. THERE WAS NO REPORT OF USER OR PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING INCOMING INSPECTION, IT WAS DETERMINED THE FORCEPS PLUG MOUTHPIECE WAS SCRAPED. THIS MEDWATCH IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951318 ↗
• MalfunctionDec 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE CYSTO-NEPHRO VIDEOSCOPE EXPERIENCED A LEAK. THERE WAS NO REPORT OF USER OR PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING INCOMING INSPECTION, IT WAS DETERMINED THE FORCEPS PLUG MOUTHPIECE WAS SCRAPED. THIS MEDWATCH IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948617 ↗
• MalfunctionDec 7, 2022Peeled/Delaminated; Material Protrusion/Extrusion; Peeled/Delaminated; Material Protrusion/Extrusion

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, THE ADHESIVE ON CYSTO-NEPHRO VIDEOSCOPE WAS PEELING AT THE TIP BENDING PART AND THE INTERNAL WIRE WAS EXPOSED DURING MAINTENANCE. SIMILAR ISSUES OCCUR FREQUENTLY AT THE FACILITY AND RECENTLY CYF-VA2 WAS REPAIRED. THE FACILITY HAS 2X CYF-VHA AND 2X CYF-VA, BUT THE SAME PROBLEM IS OCCURRING WITH EACH. THE DEVICES ARE PRIMARILY CLEANED AND DISINFECTED WITH ENDOSCOPE REPROCESSOR (OER-4). AT THE END OF THE DAY GO THROUGH AN ETHYLENE OXIDE GAS STERILIZATION. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. EVENT 2 OF 4 THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE 2:2 CYSTO-NEPHRO VIDEOSCOPE (CYF-VHA), UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH 1:2 CYSTO-NEPHRO VIDEOSCOPE (CYF-VHA) DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH 1:2 VISERA CYSTOVIDEOSCOPE (CYF-VA) DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH 2:2 VISERA CYSTOVIDEOSCOPE (CYF-VA) DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936966 ↗
• MalfunctionDec 7, 2022Peeled/Delaminated; Material Protrusion/Extrusion; Peeled/Delaminated; Material Protrusion/Extrusion

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, THE ADHESIVE ON CYSTO-NEPHRO VIDEOSCOPE WAS PEELING AT THE TIP BENDING PART AND THE INTERNAL WIRE WAS EXPOSED DURING MAINTENANCE. SIMILAR ISSUES OCCUR FREQUENTLY AT THE FACILITY AND RECENTLY CYF-VA2 WAS REPAIRED. THE FACILITY HAS 2X CYF-VHA AND 2X CYF-VA, BUT THE SAME PROBLEM IS OCCURRING WITH EACH. THE DEVICES ARE PRIMARILY CLEANED AND DISINFECTED WITH ENDOSCOPE REPROCESSOR (OER-4). AT THE END OF THE DAY GO THROUGH AN ETHYLENE OXIDE GAS STERILIZATION. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. EVENT 1 OF 4 THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE 1:2 CYSTO-NEPHRO VIDEOSCOPE (CYF-VHA), UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH 2:2 CYSTO-NEPHRO VIDEOSCOPE (CYF-VHA) DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH 1:2 VISERA CYSTOVIDEOSCOPE (CYF-VA) DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH 2:2 VISERA CYSTOVIDEOSCOPE (CYF-VA) DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936867 ↗
• MalfunctionNov 22, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THE BENDING RUBBER OF THE SUBJECT DEVICE WAS PERFORATED. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT FOREIGN MATERIAL WAS ADHERED TO THE INSERTION TUBE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING DEVICE EVALUATION (FOREIGN MATERIAL IN INSERTION TUBE). ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED ISSUE. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845321 ↗