Accessories, Photographic, For Endoscope (Exclude Light Sources)
FDA adverse event reports and recall history for accessories, photographic, for endoscope (exclude light sources) (product code FEM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 690
- Deaths
- 0
- Injuries
- 26
- Malfunctions
- 663
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-09-22Open, ClassifiedDevice Design
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. Catalog No: 405011000
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
- 2012-03-05TerminatedEquipment maintenance
Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1 The mobile workstations are intended for use in medical facilities under the direction of a trained physician, and has been designed to be used with a range of Olympus equipment to facilitate GI endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic
Replacement wheels may break off from the base of the cart
- 2003-12-18TerminatedNonconforming Material/Component
Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced)
Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
- 2003-12-18TerminatedNonconforming Material/Component
Smith & Nephew Endocoupler C-Mount 35 mm Focal Length Reference :7204614 and 7204614S (S indicates unit previously serviced)
Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
- TerminatedUnder Investigation by firm
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.
Monitor accessories, photographic, for endoscope (exclude light sources) automatically
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