{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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(ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED SINCE PATIENT SUSTAINED AN INJURY TO THE PULMONARY ARTERY DURING THE DA VINCI LOBECTOMY PROCEDURE, WHICH WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE. THERE WAS NO ALLEGATION OF ANY MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES CONTRIBUTING TO THE PATIENT'S INJURY; HOWEVER, THE CAUSE OF THE REPORTED INJURY IS UNKNOWN." }, { "mdr_text_key": "4175645", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2014, AN INTUITIVE SURGICAL, INC. (ISI) SALES REPRESENTATIVE BECAME AWARE OF AN INJURY THAT OCCURRED DURING A DA VINCI RIGHT UPPER LOBECTOMY PROCEDURE THAT TOOK PLACE ON (B)(6) 2014 FROM A DOCTOR WHO WAS PRESENT DURING THE CASE. THE DOCTOR INDICATED THAT THE SURGEON PERFORMING THE DA VINCI SURGICAL PROCEDURE ENCOUNTERED AN INJURY TO A BRANCH OF THE PULMONARY ARTERY, WHICH BLED UNCONTROLLABLY. THE DA VINCI PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE AND THE PATIENT WAS GIVEN AN EMERGENCY HEART AND LUNG BYPASS. THE PATIENT LOST >40 UNITS OF BLOOD AND WAS GIVEN A BLOOD TRANSFUSION. THE PATIENT ALSO DEVELOPED ABDOMINAL COMPARTMENT SYNDROME AND WAS REOPENED AT THE SAME PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME. ON (B)(6) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT. THE RISK MANAGER INDICATED THAT THE PATIENT'S INJURY WAS NOT RELATED TO ANY ISSUES OR MALFUNCTIONS OF THE DA VINCI SYSTEM. SHE DECLINED TO PROVIDE ANY OTHER INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }