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.
Recall
- Recall Number
- Z-3225-2017
- Event Number
- 78065
- Firm
- Fujifilm Medical Systems U.S.A., Inc.
- FEI Number
- 2431293
- Product Code
- FDT
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 21, 2017
- Terminated
- July 12, 2018
- Address
- 10 Highpoint Dr, Wayne, NJ, 07470-7431
Description
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.
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.
On July 21, 2017, Fujifilm Medical Systems U.S.A., Inc. Endoscopy Division distributed Urgent Medical Device Correction and Removal notices & Field Action Verification Forms to their U.S. Consignees by USPS certified mail. Fujifilm Medical Systems will contact all customers that have the duodenoscope by October 2017, with details for returning the device for replacement parts. This field action allows continued use of the current device until you are contacted by a sales representative for replacement parts as early as October 2017. While the remediation of the scopes will take approximately two weeks to complete, Fujifilm Medical Systems U.S.A. Inc. Endoscopy Division will provide interim duodenoscopes on loan for continuity of care. Once received, the recalling firm will replace the forceps elevator mechanism with O-ring and the distal end cap. An updated manual has been generated to include new information/guidance. Customers are encouraged to complete and return the Field Action Verification Form via email to [email protected] or via fax to (973) 872-4723. Customers with questions can call Larry Picciano, Sr. Director Quality and Regulatory Affairs at (973) 686-2479.
Nationwide
362 units