FDA Enforcement
Class II
Terminated
Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Recall: Z-2078-2016
·
Reported July 6, 2016
Enforcement
- Recall Number
- Z-2078-2016
- Event ID
- 73894
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Pentax Medical Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 6, 2016
- Initiation Date
- April 6, 2016
- Classification Date
- June 28, 2016
- Termination Date
- December 21, 2017
- Address
- 3 Paragon Dr, Montvale, NJ, 07645-1782, United States
Description
Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
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 Info
Model #'s FUR-9P and FUR-9RBS
Distribution
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Quantity
32 units