Light Source, Endoscope, Xenon Arc
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
2,332 adverse event reports on file
- EVIS LUCERA ELITE XENON LIGHT SOURCEJul 30, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26214
- VISERA 4K UHD XENON LIGHT SOURCEJul 30, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26275
- EVIS LUCERA ELITE XENON LIGHT SOURCEJul 30, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26281
- EVIS LUCERA ELITE XENON LIGHT SOURCEJul 29, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-25990
- EVIS LUCERA ELITE XENON LIGHT SOURCEJul 29, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26016
- EVIS LUCERA ELITE XENON LIGHT SOURCEJul 29, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26018
- VISERA 4K UHD XENON LIGHT SOURCEJul 29, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26048
- EVIS LUCERA ELITE XENON LIGHT SOURCEJul 29, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-26098
- EVIS LUCERA ELITE XENON LIGHT SOURCEJul 28, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-25695
- EVIS LUCERA ELITE XENON LIGHT SOURCEJul 28, 2026MalfunctionShirakawa Olympus Co., Ltd.3002808148-2026-25778
Event type breakdown
Recalls
3 recall events for this product code
- Linvatec Corp. dba ConMed LinvatecTerminatedSep 25, 2012
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
Z-2455-2012 · View FDA record ↗ - Linvatec Corp. dba ConMed LinvatecTerminatedSep 25, 2012
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
Z-2456-2012 · View FDA record ↗ - Linvatec ImagingTerminatedSep 10, 2005
Linvatec LS 7500, 300 Watt Xenon Light Source
Through the complaint handling system, the company has determine there are performance issued involving the LS7500, 300 Watt Xenon Light Source. The performance issues result in a low light output that can create poor illumination of the surgical site.
Z-1531-05 · View FDA record ↗
Registered firms
70 firms currently registered for this product code
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Linvatec Corporation
LARGO, FL, US
Medtronic Neurosurgery
Fort Worth, TX, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Consolidated Medical Equipment Company
Chihuahua, MX
Novaprobe Inc.
Lansdale, PA, US
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
Sklar Corporation - Warehouse
Salisbury, MD, US
Heinrich Medizintechnik Gmbh
Stuttgart Baden-Wurttemberg, DE
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Mardav Solutions Ltd
Manchester, GB
Gulf Fiberoptics, Inc.
OLDSMAR, FL, US
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Karl Storz Endovision, Inc.
CHARLTON, MA, US
Hoya Corporation Pentax Lifecare Division
Akishima-shi Tokyo, JP
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Storz Endoskop Produktions Gmbh
SCHAFFHAUSEN, CH
Conmed Corporation
Utica, NY, US
510(k) clearances
47 clearances for this product code
- Gimmi GmbHJan 27, 2010
K093125 · ALPHAXENON LIGHT 180 W AND 300 W
- KARL STORZ Endoscopy-America, Inc.Dec 18, 2008
K082925 · XENON-100 SCB LIGHT SOURCE, MODEL 20132620
- Conmed LinvatecAug 20, 2007
K070376 · CONMED LINVATEC 300W XENON LIGHT SOURCE
- Acueity, Inc.May 7, 2004
K040949 · VIADUCT MINISCOPE AND ACCESSORIES
- KARL STORZ Endoscopy-America, Inc.Sep 29, 2003
K022490 · KSEA MEDI PACK
- Linvatec Corp.Aug 21, 2003
K031994 · LINVATEC 300W XENON LIGHT SOURCE
- World of Medicine Lemke GmbHJan 14, 2003
K023468 · ENDOSCOPIC LIGHT SOURCE XL180/L3
- World of Medicine Lemke GmbHAug 20, 2002
K021717 · ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5