Confocal Optical Imaging
Gastroenterology, Urology · 21 CFR 876.1500
Collection of light signals for visualization of cellular microstructures.
Recent MDR events
1,525 adverse event reports on file
- VISERA ELITE II XENON LIGHT SOURCEJul 30, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-25953
- VISERA ELITE II XENON LIGHT SOURCEJul 30, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26309
- HOPKINS RUBINA 0°, NIR/ICG, Ø 5 mmJul 29, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01768
- 1588 AIM CAMERA CONTROL UNIT CCU - INTERNATIONAL KITJul 29, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00544
- SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM INTERNATIONAL KIJul 28, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00519
- PKG L12 LED LIGHT SOURCE WITH AIMJul 28, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00538
- POWER LED RUBINA, OPAL1 NIR/ICGJul 21, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01687
- POWER LED RUBINA, OPAL1 NIR/ICGJul 21, 2026InjuryKarl Storz Se & Co. Kg9610617-2026-01687
- FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MMJul 15, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00482
- PKG L11 LED LIGHT SOURCE WITH AIMJul 14, 2026MalfunctionStryker Endoscopy-san Jose0002936485-2026-00471
Event type breakdown
Recalls
4 recall events for this product code
- Olympus Corporation of the AmericasOpen, ClassifiedOct 25, 2024
Quest Spectrum 3 Fluorescent Imaging System
Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention
Z-0232-2025 · View FDA record ↗ - Visionsense, Ltd.Open, ClassifiedNov 23, 2022
VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR)
Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
Z-0280-2023 · View FDA record ↗ - Visionsense, Ltd.Open, ClassifiedNov 23, 2022
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm
XXX
Z-0281-2023 · View FDA record ↗ - Visionsense, Ltd.Open, ClassifiedNov 23, 2022
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner)
Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
Z-0282-2023 · View FDA record ↗
Registered firms
188 firms currently registered for this product code
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Device Technologies Australia
Marsden Park New South Wales, AU
Activ Surgical Inc
Boston, MA, US
Expeditors International Bv
Amsterdam Noord-Holland, NL
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Stryker Endoscopy
SAN JOSE, CA, US
Mauna Kea Technologies
PARIS Ile-de-France, FR
Life Science Logistics, Llc
Brownsburg, IN, US
Fibertech Co., Ltd.
Sakura-shi Chiba, JP
Prolinair Asia Limited
Ha Tsuen, Yuen Long, N.T., HK
Storz Endoskop Produktions Gmbh
SCHAFFHAUSEN, CH
Arthrex California Technology, Incorporated
Santa Barbara, CA, US
Arthrex, Inc.
Ave Maria, FL, US
Cyber Robotic Solutions S.a. De C.v.
Ciudad de Mexico, MX
Arvato Se
Hamburg, DE
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Device Technologies New Zealand
Albany Auckland, NZ
510(k) clearances
62 clearances for this product code
- LIMIS Development B.V.Jul 24, 2026
K254180 · PerfusiX-Imaging
- SmartsurgN, Inc.Apr 20, 2026
K242163 · SmartSurgN Visualization System
- Karl Storz SE & CO. KGFeb 26, 2026
K254242 · KARL STORZ ICG Imaging System with RUBINA® Lens
- VPIX Medical, Inc.Feb 13, 2026
K251852 · cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
- Karl Storz SE & CO. KGFeb 12, 2026
K253972 · IMAGE1 (TC400US); X-to-4U Adapter (TC040)
- Stryker EndoscopyFeb 12, 2026
K260108 · L12 LED Light Source with AIM
- Olympus Medical Systems Corp.Nov 12, 2025
K251336 · VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
- Wuxi Hisky Medical Technologies Co., Ltd.Jul 24, 2025
K243711 · Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);