Cystoscope And Accessories, Flexible/Rigid
FDA adverse event reports and recall history for cystoscope and accessories, flexible/rigid (product code FAJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 9,923
- Deaths
- 3
- Injuries
- 780
- Malfunctions
- 9,094
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-5, Cystonephrofiberscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-5R, Cystonephrofiberscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2024-01-09Open, ClassifiedUnder Investigation by firm
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- 2023-11-17Open, ClassifiedUnder Investigation by firm
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
- 2016-06-28TerminatedDevice Design
Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 2016-04-14TerminatedPackaging
Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- 2015-09-03TerminatedPackaging
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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