OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5A (UDI 04953170339424)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 04953170339424), received between Sep 28, 2021 and Jun 9, 2025 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE CYSTONEPHROFIBERSCOPE'S WORKING CHANNEL VALVE BECAME DETACHED. THERE WAS NO INDICATION DURING WHAT TYPE OF DEVICE USAGE THE REPORTED EVENT OCCURRED. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167257 ↗
• MalfunctionMay 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE CYSTONEPHROFIBERSCOPE HAD A BENT INSERTION SECTION OBSERVED DURING SETUP/INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965170 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THE CYSTONEPHROFIBERSCOPE HAD A BROKEN TIP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428641 ↗
• MalfunctionOct 4, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20375586 ↗
• MalfunctionJul 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED 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 19783094 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CYSTONEPHROFIBERSCOPE EXHIBITED A DAMAGED CHANNEL TUBE PORT, WITH THE BIOPSY PORT HAVING BECOME DETACHED. ADDITIONALLY, THE SCREW THREAD AT THE BIOPSY PORT HAD SLIPPED, PREVENTING THE BIOPSY PORT FROM BEING SECURELY TIGHTENED. THE EVENT WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166381 ↗
• MalfunctionApr 7, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTONEPHROFIBERSCOPE EXHIBITED A BROKEN CHANNEL TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057057 ↗
• MalfunctionMar 21, 2024Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  IT WAS REPORTED, THE FLEXIBLE SCOPE EXHIBITED A LEAK. THE ISSUE OCCURRED DURING A THERAPEUTIC STENT REPLACEMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955442 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTONEPHROFIBERSCOPE EXHIBITED THE IMAGE GUIDE (IG) PIPE RESIN PART FALLING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18805386 ↗
• MalfunctionDec 19, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE CYSTONEPHROFIBERSCOPE HAD AN AIR/WATER LEAK. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION/REPAIR. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THERE WAS RESIDUAL LIQUID/FOREIGN MATERIAL IN THE CHANNEL TUBE. 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 18360564 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES CYSTONEPHROFIBERSCOPE HAD A RUBBER PINHOLE SEPARATION. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND; THE FORCEPS STOPPER HAD COME OFF. 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 18259068 ↗
• MalfunctionNov 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CYSTONEPHROFIBERSCOPE HAD FLEXIBLE MESH PROTRUDING OUTWARD. THIS ISSUE WAS FOUND DURING REPROCESSING. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108920 ↗
• MalfunctionNov 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTONEPHROFIBERSCOPE HAD THE RUBBER GASKET AT THE BASE OF THE FORCEPS PLUG RISE, CAUSING INTERMITTENT AIR FLOW. THE ISSUE WAS FOUND DURING REPROCESSING WITH THE PROCEDURE BEING COMPLETED. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING THE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE FORCEPS MOUTHPIECE WAS DISLODGED. 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 18097491 ↗
• MalfunctionOct 30, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED THAT THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUES WERE FOUND DURING REGULAR EXAMINATION IN THE HOSPITAL. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028143 ↗
• MalfunctionOct 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTO-NEPHRO FIBERSCOPE WAS BEING REPROCESSED PRIOR TO USE FOR A DIAGNOSTIC PROCEDURE AND THE FORCEPS OPENER CAME OFF. THE PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856953 ↗
• MalfunctionSep 15, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTONEPHROFIBERSCOPE THE BENDING SECTION COVER RUBBER (CURVED RUBBER) WAS DAMAGED AFTER REPROCESSING. THE ISSUE WAS OBSERVED DURING REPROCESSING. NO PATIENT OR PROCEDURE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754512 ↗
• MalfunctionSep 12, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTONEPHROFIBERSCOPE HAD A BLURRY IMAGE. THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR A DEVICE EVALUATION AND FOUND FOREIGN MATERIAL ATTACHED TO THE OBJECTIVE LENS. 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 17730275 ↗
• MalfunctionSep 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTONEPHROFIBERSCOPE VENTILATION TUBE (T TUBE) MOUNTING MOUTHPIECE'S PACKING WAS TORN AND THERE WAS A DETACHMENT OF THE T-TUBE ATTACHMENT PORT. THE ISSUE OCCURRED AFTER USE IN A URETERAL STENT PLACEMENT WHICH WAS COMPLETED WITHOUT DELAY. THE CUSTOMER REPORTED THAT A SOFT STONE WAS PRESENT IN THE BLADDER AND ADHERED TO THE STENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725773 ↗
• MalfunctionSep 8, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE OES CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR 2 COLONY FORMING UNITS (CFUS) OF MICROORGANISM REVIVABLE AT 30 DEGREES C. 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 17712282 ↗
• MalfunctionSep 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTONEPHROFIBERSCOPE FORCEPS WAS OUT OF THE MOUTH. THE ISSUE WAS FOUND WHEN REMOVING THE CLEANING TUBE AFTER CLEANING. THE PROCEDURE WAS COMPLETED AND "END CLEANSE" WAS USED IN COMBINATION WITH THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698897 ↗
• MalfunctionAug 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, THE OES CYSTONEPHROFIBERSCOPE HAD A T-SHAPED PIPE COME OFF DURING REPROCESSING. THE DIAGNOSTIC CYSTOSCOPY WAS COMPLETED WITHOUT DELAY. THERE WAS NO REPORT OF USER OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17578026 ↗
• MalfunctionAug 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTONEPHROFIBERSCOPE HAD BROKEN FORCEPS CHANNEL, UNABLE TO REMOVE TEE TUBE DURING REPROCESSING. UPON INSPECTION AND EVALUATION, THE FORCEPS STOPPER DETACHMENT. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING INCOMING INSPECTION AND EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538225 ↗
• MalfunctionAug 8, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES CYSTONEPHROFIBERSCOPE HAD DEFECTS IN THE DISTAL END. NO REPORTS OF PATIENT HARM WERE ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR A DEVICE EVALUATION AND FOUND THE FORCEPS CHANNEL PORT 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 17483981 ↗
• MalfunctionJul 17, 2023Break; Break

  A USER FACILITY REPORTED TO OLYMPUS A BROKEN FORCEPS CAP ON OES CYSTONEPHROFIBERSCOPE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334605 ↗
• MalfunctionJun 23, 2023Material Rupture; Material Rupture

  AN OLYMPUS SENIOR FIELD SERVICE ENGINEER REPORTED ON BEHALF OF A CUSTOMER, THE BENDING SECTION RUBBER RUPTURED, THE METAL WAS STICKING OUT AND THERE WAS NOT SUFFICIENT ANGULATION ON THE OES CYSTONEPHROFIBERSCOPE. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190313 ↗