OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5A (UDI 04953170286964)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170286964), received between Jul 15, 2022 and Nov 25, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2024Defective Device; Defective Device

  IT WAS REPORTED THE CYSTONEPHROFIBERSCOPE DAMAGED EXTERNALLY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771524 ↗
• MalfunctionSep 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CYSTONEPHROFIBERSCOPE HAD A DAMAGED FORCEPS PORT. THIS WAS FOUND WHEN CLEANING UP AFTER A DIAGNOSTIC MEDICAL EXAMINATION. THE PROCEDURE HAD BEEN COMPLETED PRIOR TO THE EVENT WITH NO DELAY, USING THE SAME DEVICE WITHOUT ANY PROBLEMS. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17762422 ↗
• MalfunctionAug 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CYSTONEPHROFIBERSCOPE HAD A PINHOLE ON ITS BENDING SECTION COVER. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED, EVALUATED, AND IT WAS FOUND THAT THE FORCEPS PLUG MOUTHPIECE WAS SCRAPED. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17472243 ↗
• MalfunctionJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE T-TUBE ATTACHMENT PART OF THE OES CYSTONEPHROFIBERSCOPE WAS DISCONNECTED. THIS WAS FOUND WHILE THE DEVICE WAS BEING CLEANED. THERE WAS NO DELAY TO THE INTENDED PROCEDURE, AND NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225829 ↗
• MalfunctionMay 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES CYSTONEPHROFIBERSCOPE HAS A BROKEN FORCEPS MOUTH. THE REPORTED ISSUE OCCURRED, DURING REPROCESSING PRIOR TO PREPARATION OF USE FOR AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872823 ↗
• MalfunctionMar 16, 2023Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO OLYMPUS THE OES CYSTONEPHROFIBERSCOPE BIOPSY PORT WAS LOOSE AND DETACHED. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561428 ↗
• MalfunctionFeb 22, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THE OES CYSTONEPHROFIBERSCOPE HAD AIR/WATER LEAKS. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND FORCEPS CHANNEL PORT WAS LOOSE. THE REPORT IS BEING SUBMITTED DUE TO LOOSE PORT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417135 ↗
• MalfunctionOct 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, FOR AN OES CYSTONEPHROFIBERSCOPE FORCEPS CHANNEL HAD CONNECTION FAILURE. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE SCOPE FORCEPS PLUG MOUTHPIECE WAS DETACHED. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15664634 ↗
• MalfunctionJul 15, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, FOR THE OES CYSTONEPHROFIBERSCOPE FORCEPS PLUG MOUTHPIECE GAP WAS, LOOSENESS, DEFORMATION, SCRAPING, RATTLING, AND DETACHMENT TILTING OF THE INSTRUMENT CHANNEL PORT MOUNTING BASE-DAMAGED AND DEFORMED. THERE WAS NO PATIENT INVOLVEMENT, OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15028959 ↗