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Recall Observatory FDA recall evidence

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

May 21, 2015

Class II

Product summary

Firm
Intuitive Surgical, Inc.
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

    reason.no_named_rule · v1.0.0

    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.