Device product
Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Z-2072-2016
Product summary
- Event
- Event 73894
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,220 units
- Official record key
device-enforcement:Z-2072-2016
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 FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS and FI-9RBS
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.