Device product
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
Z-1812-2015
Product summary
- Event
- Event 71285
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,436 units
- Official record key
device-enforcement:Z-1812-2015
Official wording
Reason: The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.
Code information: version 420343-01 and 420323-02, all lots
Distribution pattern: Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.
Derived failure modes
-
Unknown
The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.