Device product
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Z-3225-2017
Product summary
- Event
- Event 78065
- Status
- Terminated
- Classification
- Class II
- Quantity
- 362 units
- Official record key
device-enforcement:Z-3225-2017
Official wording
Reason: An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
Code information: All lots/serial numbers
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.