Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
FDA Recall Z-1812-2015 · Posted 2015-06-17
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2015-05-21
Date Terminated2018-07-02
Product Quantity2,436 units
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.
Firm Action
Urgent Medical Device Recall letters were sent to all consignees on May 21, 2015.
The letter describes the affected product and issue involved. Additionally, the risk to health, as well as the actions to be taken were also discussed in the letter. Customers are to ensure that all affected personnel were informed of the notice. All affected product are to be identified and returned by contacting Customer Service for a RMA. The Acknowledgment Form is to be completed and returned using the instructions provided. If further information or support concerning this recall is needed, customers are to contact their local Clinical Sales Representative or Intuitive Surgical Customer Service.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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