Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
Reported: June 24, 2015 Initiated: May 21, 2015 #Z-1812-2015
Product Description
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
Reason for Recall
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 2,436 units
- Distribution
- Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.. Recalled by Intuitive Surgical, Inc.. Units affected: 2,436 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2015. Severity: Moderate. Recall number: Z-1812-2015.
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