Accessories, Photographic, For Endoscope (exclude Light Sources)
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
698 adverse event reports on file
- COUPLER AC ZOOM CHINA LOCALJul 28, 2026MalfunctionMedos International Sã rl1221934-2026-03335
- COUPLER AC ZOOMJul 21, 2026MalfunctionMedos International Sã rl1221934-2026-03184
- WM-DP3 MOBILE WORKSTATION USJul 21, 2026MalfunctionKeymed (medical And Industrial Equipment) Ltd.9611174-2026-00144
- COUPLER AC ZOOM CHINA LOCALJul 14, 2026MalfunctionMedos International Sã rl1221934-2026-03052
- COUPLER AC FFL 19Jul 10, 2026MalfunctionMedos International Sã rl1221934-2026-03002
- COUPLER AC FFL 19Jul 10, 2026MalfunctionMedos International Sã rl1221934-2026-02971
- FUSIONJul 8, 2026InjuryRichard Wolf Gmbh9611102-2026-00042
- COUPLER AC FFL 19Jul 6, 2026MalfunctionMedos International Sarl1221934-2026-02909
- COUPLER AC FFL 19Jun 19, 2026MalfunctionMedos International Sã rl1221934-2026-02704
- COUPLER AC ZOOM CHINA LOCALJun 18, 2026MalfunctionMedos International Sarl1221934-2026-02664
Event type breakdown
Most-reported manufacturers
Recalls
5 recall events for this product code
- Ambu Inc.Open, ClassifiedSep 22, 2023
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system.
Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames
Z-2628-2023 · View FDA record ↗ - Olympus America Inc.TerminatedMar 5, 2012
Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1
Replacement wheels may break off from the base of the cart
Z-1160-2012 · View FDA record ↗ - Smith And Nephew, Inc. Endoscopy DivisionTerminatedDec 18, 2003
Smith & Nephew Endocoupler C-Mount 30mm Focal Length
Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
Z-0247-04 · View FDA record ↗ - Smith And Nephew, Inc. Endoscopy DivisionTerminatedDec 18, 2003
Smith & Nephew Endocoupler C-Mount 35 mm Focal Length
Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
Z-0248-04 · View FDA record ↗ - Olympus Corporation of the AmericasTerminatedUnknown
Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds.
Z-1983-2019 · View FDA record ↗
Registered firms
63 firms currently registered for this product code
Fujifilm Healthcare Manufacturing Corporation Hanamaki Office
HANAMAKI-SHI Iwate, JP
Hunan Vathin Medical Instrument Co., Ltd.
Xiangtan Hunan, CN
Shenzhen Besdata Technology Co.,ltd
Shenzhen Guangdong, CN
Arthrex, Inc.
Ave Maria, FL, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Aspen Surgical Products, Inc.
Caledonia, MI, US
Ambu A/s
Ballerup Hovedstaden, DK
Invidia Medical Gmbh U Co Kg
Emmingen-Liptingen Baden-Wurttemberg, DE
Biogenomics S.a.c. - Biocells Surgical
Lima, PE
Transamerican Technologies International
SAN RAMON, CA, US
Hoya Corporation Pentax Lifecare Division
KURIHARA-SHI Miyagi, JP
Zhongshan Wesee Meditech Co., Ltd.
Zhongshan Guangdong, CN
Crosmed S.a.
Buenos Aires, AR
Depuy Synthes Sales
Bridgewater, MA, US
Geotec, Inc.
Warwick, RI, US
Arthrex, Inc.
Naples, FL, US
Mardav Solutions Ltd
Manchester, GB
Hoya Corporation Pentax Lifecare Division
Akishima-shi Tokyo, JP
Sapi Med S.p.a
ALESSANDRIA, IT
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Asap Endoscopic Products Gmbh
Umkirch Baden-Wurttemberg, DE
Fujifilm Healthcare Manufacturing Corporation Sano Office
Sano City Tochigi, JP
Highridge Medical, Llc
Westminster, CO, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Medithinq Co., Ltd.
Seongnam Gyeonggi, KR
510(k) clearances
4 clearances for this product code