Cystoscope And Accessories, Flexible/rigid
Gastroenterology, Urology · 21 CFR 876.1500
To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Recent MDR events
10,640 adverse event reports on file
- CYSTO-NEPHRO VIDEOSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26382
- CYSTO-NEPHRO VIDEOSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26389
- CYSTO-NEPHRO VIDEOSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26394
- CYSTO-NEPHRO VIDEOSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26396
- CYSTO-NEPHRO VIDEOSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26399
- OES CYSTONEPHROFIBERSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26405
- CYSTO-NEPHRO VIDEOSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26408
- OES CYSTONEPHROFIBERSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26415
- CYSTO-NEPHRO VIDEOSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26430
- OES CYSTONEPHROFIBERSCOPEJul 31, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26437
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Detachment of Device or Device Component”
Recalls
22 recall events for this product code
- Shirakawa Olympus Co., Ltd.Open, ClassifiedJan 9, 2024
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.
Z-0684-2024 · View FDA record ↗ - Shirakawa Olympus Co., Ltd.Open, ClassifiedJan 9, 2024
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.
Z-0685-2024 · View FDA record ↗ - Shirakawa Olympus Co., Ltd.Open, ClassifiedJan 9, 2024
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.
Z-0689-2024 · View FDA record ↗ - Shirakawa Olympus Co., Ltd.Open, ClassifiedJan 9, 2024
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.
Z-0690-2024 · View FDA record ↗ - Shirakawa Olympus Co., Ltd.Open, ClassifiedJan 9, 2024
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.
Z-0691-2024 · View FDA record ↗ - Shirakawa Olympus Co., Ltd.Open, ClassifiedJan 9, 2024
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.
Z-0692-2024 · View FDA record ↗ - Aizu Olympus Co., Ltd.Open, ClassifiedNov 17, 2023
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney
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
Z-0331-2024 · View FDA record ↗ - Pentax Medical CompanyTerminatedJun 28, 2016
Cystoscope
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.
Z-2070-2016 · View FDA record ↗ - Customed, IncTerminatedApr 14, 2016
Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1407-2016 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2558-2015 · View FDA record ↗
Registered firms
273 firms currently registered for this product code
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Ambu Sdn.bhd.
PENANG Pulau Pinang, MY
Opcom Medical Inc.
New Taipei City, TW
Prosurg, Inc
San Jose, CA, US
Opcom Inc.
New Taipei City, TW
Tekno Medical Optik-chirurgie Gmbh
TUTTLINGEN-Nendingen Baden-Wurttemberg, DE
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Customed, Inc.
Fajardo, PR, US
Guangzhou Red Pine Medical Instrument Co.,ltd.
Guangzhou Guangdong, CN
Richard Wolf Medical Instruments Corp.
VERNON HILLS, IL, US
Uroviu Corporation
Los Altos, CA, US
Hunan Vathin Medical Instrument Co., Ltd.
Xiangtan Hunan, CN
Zenflow, Inc.
South San Francisco, CA, US
Henke-sass Wolf, Gmbh.
TUTTLINGEN Baden-Wurttemberg, DE
Degania Silicone, Ltd.
DEGANIA BET Northern, IL
International Medical Lasers, Inc.
Tualatin, OR, US
Gyrus Acmi, Inc.
Westborough, MA, US
Shirakawa Olympus Co., Ltd.
NISHISHIRAKAWA-GUN Fukushima, JP
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Stryker Emea Supply Chain Services
Venlo Limburg, NL
Hoya Corporation Pentax Lifecare Division
KURIHARA-SHI Miyagi, JP
510(k) clearances
92 clearances for this product code
- Olympus Winter & Ibe GmbHMay 21, 2026
K260649 · OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,
- Verathon Medical (Canada) UlcMay 11, 2026
K253696 · CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
- Strauss Surgical USAApr 16, 2026
K253892 · Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,
- Cogentix Medical, Inc.Apr 7, 2026
K253905 · PrimeSight UltraView System
- American Medical Endoscopy, Inc.Mar 27, 2026
K260271 · Strauss Surgical cystoscope, hysteroscope and accessories Instruments
- Uroviu CorporationOct 23, 2025
K253226 · UV5000W Handle
- Zenflow, Inc.Sep 23, 2025
K251140 · Zenflow Spring Scope
- Shanghai AnQing Medical Instrument Co., Ltd.Sep 15, 2025
K252598 · Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)