Device product
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Z-2277-2016
Product summary
- Event
- Event 73985
- Status
- Terminated
- Classification
- Class II
- Quantity
- 433 units
- Official record key
device-enforcement:Z-2277-2016
Official wording
Reason: Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Code information: Model #'s FD-34V and ED-3490TK
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.