Device product
Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Z-2069-2016
Product summary
- Event
- Event 73894
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-2069-2016
Official wording
Reason: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Code information: Model #'s EG-3870CIK, EC-3870CILK
Distribution pattern: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Derived failure modes
-
Unknown
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.