Light Source, Fiberoptic, Routine
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
2,959 adverse event reports on file
- PUREVUE CCS LIGHT CHINA LOCALJul 31, 2026MalfunctionMedos International Sã rl1221934-2026-03390
- PUREVUE CCS LIGHT CHINA LOCALJul 29, 2026MalfunctionMedos International Sã rl1221934-2026-03370
- PUREVUE CCS LIGHT CHINA LOCALJul 28, 2026MalfunctionMedos International Sã rl1221934-2026-03326
- PUREVUE CCS LIGHT CHINA LOCALJul 28, 2026MalfunctionMedos International Sã rl1221934-2026-03328
- PUREVUE AIOJul 27, 2026MalfunctionJohnson & Johnson Medical (suzhou) Ltd.3005075853-2026-05893
- MLX 300W XENON LIGHTSOURCEJul 27, 2026MalfunctionIntegra Lifesciences (ireland) Ltd.3006697299-2026-00060
- MLX 300W XENON LIGHTSOURCEJul 21, 2026MalfunctionIntegra Lifesciences (ireland) Ltd.3006697299-2026-00061
- PUREVUE CCS LIGHT CHINA LOCALJul 16, 2026MalfunctionMedos International Sã rl1221934-2026-03147
- ALL-IN-ONE CCU+LIGHT ROWJul 16, 2026MalfunctionMedos International Sã rl1221934-2026-03153
- PUREVUE CCS LIGHT CHINA LOCALJul 15, 2026MalfunctionMedos International Sã rl1221934-2026-03091
Event type breakdown
Recalls
5 recall events for this product code
- Stryker CorporationOpen, ClassifiedApr 28, 2023
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
Z-1474-2023 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedDec 2, 2011
Integra Surgical Luxtec MLX Light Source
A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
Z-0356-2012 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedDec 2, 2011
Integra Surgical Luxtec MLX Light Source
A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
Z-0357-2012 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedDec 2, 2011
Integra Surgical Luxtec MLX Light Source
A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
Z-0358-2012 · View FDA record ↗ - Integra LifeSciences Corp.TerminatedApr 25, 2011
Luxtec MLX 300 Watt Xenon Light Source,
Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.
Z-2060-2011 · View FDA record ↗
Registered firms
98 firms currently registered for this product code
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Stryker Endoscopy
SAN JOSE, CA, US
Expeditors International Bv
Amsterdam Noord-Holland, NL
Conmed Corporation
Utica, NY, US
Medos International Sarl
Le Locle Neuchatel, CH
Integra Canada Ulc
Oakville Ontario, CA
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Hayden Medical Inc
Valencia, CA, US
Br Surgical Llc
Jacksonville, FL, US
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Hoya Corporation Pentax Lifecare Division
KURIHARA-SHI Miyagi, JP
Integra Lifesciences Corporation
Princeton, NJ, US
Linvatec Corporation
LARGO, FL, US
Sunoptic Technologies, Llc
JACKSONVILLE, FL, US
Stryker Emea Supply Chain Services
Venlo Limburg, NL
Karl Storz Endoscopy Canada Ltd.
Mississauga Ontario, CA
Karl Storz Endovision, Inc.
CHARLTON, MA, US
Carestream Health, Inc.
Rochester, NY, US
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
510(k) clearances
31 clearances for this product code
- Novaprobe IncorporatedJul 24, 2014
K131226 · NOVAPROBE LED LIGHT SOURCE
- KARL STORZ Endoscopy-America, Inc.Jan 25, 2013
K123956 · POWER LED 175
- Olive Medical Corp.Dec 19, 2012
K123359 · OVS1 VIDEO SYSTEM
- Richard Wolf Medical Instruments Corp.Sep 20, 2012
K121724 · ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
- Sunoptic Technologies, LLCMar 18, 2010
K093792 · LED LIGHT SOURCE
- KARL STORZ Endoscopy-America, Inc.Sep 14, 2009
K091968 · KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
- Stryker Corp.Dec 19, 2008
K082813 · STRYKER LED LIGHTSOURCE
- Integra Luxtec, Inc.Jun 18, 2008
K081477 · LUXTEC MLX LIGHT SOURCE