OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5A (UDI 04953170292521)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04953170292521), received between May 9, 2022 and Nov 20, 2024 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE SCOPE TESTED POSITIVE FOR 3 COLONY FORMING UNITS (CFUS) OF MICRO-ORGANISMS. ALL CHANNELS WERE SAMPLED. 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 20736402 ↗
• MalfunctionOct 22, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF UNSPECIFIED MICROBES. ALL CHANNELS WERE SAMPLED. 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 20509703 ↗
• MalfunctionSep 30, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OES CYSTONEPHROFIBERSCOPE HAD A FOREIGN MATERIAL IN THE EYEPIECE BODY, FIXATION RING, CONTROL BODY, ANGLE LEVER, CONNECTION, UP/DOWN ANGULATION LEVER PLATE, FORCEPS ELEVATOR, GRIP COVER AND GRIP VENT CAP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333077 ↗
• MalfunctionSep 16, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED, THE CYSTONEPHROFIBERSCOPE HAD FOREIGN MATTER STUCK IN THE SUCTION PORT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232215 ↗
• MalfunctionJul 26, 2024Break; Material Separation; Break; Material Separation

  IT IS FURTHER REPORTED THAT THE TIP COMPONENT INCLUDING THE BENDING SECTION COVER DETACHED AND FELL OFF DUE TO LOOSENING AND DETACHMENT OF COMPONENT JOINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844036 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT THE CYSTONEPHROFIBROSCOPE. HAD A T-SHAPED PIPE FITTING CAP, THAT HAD COME OFF. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808611 ↗
• MalfunctionJul 11, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTONEPHROFIBERSCOPE EXHIBITED FOREIGN OBJECTS IN THE EYEPIECE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720427 ↗
• MalfunctionJul 8, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  PRODUCT INVOLVED WAS A CYSTONEPHROFIBERSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696951 ↗
• MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CYSTONEPHROFIBERSCOPE EXHIBITED DETACHMENT OF THE FORCEPS CHANNEL PORT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684545 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE CYSTONEPHROFIBERSCOPE FORCEPS CHANNEL PORT WAS DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552853 ↗
• MalfunctionJun 13, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE CYSTONEPHROFIBERSCOPE HAD BLACK WATER COME OUT DURING FLUSHING WHILE CLEANING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529111 ↗
• MalfunctionJun 4, 2024Material Separation; Material Separation

  IT WAS REPORTED, THE CYSTONEPHROFIBERSCOPE HAD SEPARATION ON THE BIOPSY VALVE. THE ISSUE OCCURRED DURING REPROCESSING. THE UNSPECIFIED DIAGNOSTIC PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460737 ↗
• MalfunctionMay 16, 2024Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT DEVICE HAD BEEN PREVIOUSLY WASHED, TESTED FOR LEAKS, FITTED WITH A SEALING CAP AND STERILIZED IN PLASMA, AS WITH THE OTHER 8 DEVICES THAT HAVE BEEN PROVIDED THIS MONTH, AND NOTHING HAS HAPPENED TO ANY OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19329346 ↗
• MalfunctionFeb 19, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE OLYMPUS DEVICE EVALUATION THE CYSTONEPHROFIBERSCOPE EXHIBITED A DETACHED FORCEPS CHANNEL INSERTION PORT AND FOREIGN OBJECTS IN THE LIGHT GUIDE (LG) LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18729768 ↗
• MalfunctionFeb 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEXIBLE SCOPE EXHIBITED THAT THE MOUTH GUARD PIECE FOR THE ENDOSCOPY WAS DETACHED. THE EVENT WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640674 ↗
• MalfunctionDec 28, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS, THE BENDING RUBBER IS BROKEN/TORN/RUPTURED AND THE METAL IS STICKING OUT ON THE CYSTONEPHROFIBERSCOPE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407702 ↗
• MalfunctionDec 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTONEPHROFIBERSCOPE, THE GASKET OF THE FORCEPS MOUTH WAS FLOATING, AND WATER WAS COMING OUT FROM THE ELECTROOCULOGRAM (EOG) MOUTHPIECE. VISIBILITY WAS ALSO CLOUDY AND THERE WAS A POSSIBILITY OF FLOODING. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING MALFUNCTION WAS FOUND THE FORCEPS SUCTION CONNECTER WAS DETACHED. 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 18384501 ↗
• MalfunctionDec 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS A LEAK, ISOLATION FOUND ON THE CYSTONEPHROFIBERSCOPE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION FOUND THE FORCEPS STOPPER HAD CAME OFF. 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 18253363 ↗
• MalfunctionNov 17, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE CYSTONEPHROFIBERSCOPE EXHIBITED IMAGE ISSUES. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. INSPECTION AND TESTING OF THE RETURNED DEVICE REVEALED THAT FOREIGN MATTER WAS ADHERING TO THE OBJECTIVE LENS, WHICH WAS ATTRIBUTABLE TO INSUFFICIENT CLEANING AND WIPING OF THE OBJECTIVE COVER LENS. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166389 ↗
• MalfunctionOct 24, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES CYSTONEPHROFIBERSCOPE WAS REPROCESSED IN AN ENDOSCOPE REPROCESSOR USED WITH EXPIRED ACECIDE. THE CONCENTRATION HAD NOT BEEN CHECKED, EVEN THOUGH THE FACILITY HAD ACECIDE AND CONCENTRATION CHECKERS IN STOCK. THE ACECIDE WAS USED FOR 51 DAYS BEFORE CHANGING. THIS WAS DONE INTENTIONALLY UNDER THE DIRECTION OF THE HOSPITAL DIRECTOR DUE TO THE COST OF THE ACECIDE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993386 ↗
• MalfunctionOct 17, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTONEPHROFIBERSCOPE¿S INSERT WAS PEELING OFF. THIS ISSUE WAS OBSERVED DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948789 ↗
• MalfunctionMar 10, 2023Mechanical Problem; Mechanical Problem

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE T-TUBE ON THE OES CYSTONEPHROFIBERSCOPE COULD NOT BE REMOVED. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16525695 ↗
• MalfunctionNov 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS PROVIDED. THE ISSUE OCCURRED DURING REPROCESSING AFTER A THERAPEUTIC STENT EXCHANGE PROCEDURE. THERE WERE NO PROCEDURAL DELAYS AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887025 ↗
• MalfunctionMay 9, 2022Material Deformation; Material Deformation

  CUSTOMER RETURNED THIS DEVICE FOR THE EVALUATION AND REPAIR OF IMAGE ISSUE OF STAIN IN THE IG BUNDLE. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE FORCEPS MOUTHPIECE WAS DEFORMED DUE TO PHYSICAL STRESS. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE DEFORMED FORCEPS MOUTHPIECE OBSERVED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341615 ↗