As we near the one-year anniversary of the FDA Warning Letter to Intuitive Surgical, Inc. with regard to its da Vinci Systems, the product liability lawyers at Shoop | A Professional Law Corporation continue to investigate and take on new cases involving catastrophic injuries associated with da Vinci.
FDA prepared its warning letter of July 16, 2013 to Intuitive Surgical, Inc., subsequent to an inspection of its Sunnyvale, California facility that took place between April 1, 2013 and May 30, 2013.
FDA's inspection confirmed that the following da Vinci systems were misbranded devices under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2):
- da Vinci System IS1000
- da Vinci System IS1200
- da Vinci System IS2000
- da Vinci System IS3000
FDA concluded that Intuitive Surgical, Inc. failed to provide documents or information regarding the above-referenced devices which are required by Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR 806-Medical Devices. In sum, Intuitive Surgical, Inc., failed to provide written reports to FDA within 10 working days of corrections or removals of the devices, and FDA made the following, factual findings.
In or about October of 2011, Intuitive Surgical, Inc., instituted corrections in the field by providing letters to da Vinci Surgical System clinicians and end users with accompanying suggestions for the proper use of the Tip Cover Accessory, amongst others. This particular corrective measure was in response to numerous complaints and MDRs for arcing through the damaged tip covers that caused personal injury to patients. Intuitive Surgical, Inc., did not report this corrective field action to FDA as it was required to do.
In or about October of 2011, Intuitive Surgical, Inc. instituted additional such field corrections by issuing letters to da Vinci clinicians and end users regarding the da Vinci Surgical Systems' thyroidectomy indications have not been cleared for that particular use. Intuitive Surgical, Inc., was aware of MDRs related to thyroidectomies performed via the use of the da Vinci Surgical System.
In or about October of 2011, Intuitive Surgical, Inc. instituted additional such field corrections by issuing letters to da Vinci clinicians and end users purporting to provide them with information for the inspection of the instrument cannulas, flushing of the instruments, and transport of the da Vinci Surgical System. Intuitive again failed to report this remedial field action to FDA as was required.
In or about January of 2013, Intuitive Surgical, Inc. instituted additional such field corrections by issuing letters to da Vinci clinicians and end users constituting a replacement user manual addendum. These replacement addenda included several changes to the typicality of patients and also the conditions for which da Vinci TORS is indicated, such as warnings against the use in children. Here again, Intuitive failed to report this remedial field action to FDA as was required.
The FDA inspection further revealed that the da Vinci System IS1000, da Vinci System IS3000, da Vinci System IS2000, da Vinci System IS1200 and Tip Cover Accessory, were adulterated devices as per Section 501(h) of the Act, 21 U.S.C. 351(h), because the methodology utilized in, or otherwise the facilities and/or controls for manufacture, storage, package and/or installation were not and did not adhere to the Current Good Manufacturing Practice (CGMP) requirements for medical devices as more fully set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. The specific adulterations included design input requirements which were not documented adequately [21 CFR 820.30(c)].
The medical device experts at Shoop | A Professional Law Corporation continue to represent victims nationally who were injured by da Vinci Systems. If you or a family member suffered a catastrophic injury due to this device, please contact us for a free consultation to discuss your legal rights.
Call us today for a FREE consultation at 866.884.1717