{ "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) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2010. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS RELATED TO CHRONIC PELVIC PAIN. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI S HYSTERECTOMY PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. PRIOR TO THE PROCEDURE, THE PATIENT WAS INFORMED OF THE RISK OF SURGERY INCLUDING BLEEDING, INFECTION, INJURY TO OTHER ORGANS, A ROUGHLY 10% RISK OF OPEN SURGERY, TRANSFUSION, AND RESUSCITATION, AND SIGNED CONSENT. BASED ON THE OPERATIVE REPORT, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE PROCEDURE. FROM (B)(6) 2010 THROUGH (B)(6) 2012, THE PATIENT HAD NUMEROUS CONSULTATIONS WITH VARIOUS PHYSICIANS FOR COMPLAINTS OF CHRONIC ABDOMINAL AND PELVIC PAIN. DURING THAT TIME, ALTHOUGH MULTIPLE CT SCANS, ULTRASOUND TESTS, AND MRI'S WERE PERFORMED, A DEFINITIVE ETIOLOGY FOR THE PATIENT'S SYMPTOMS COULD NOT BE DETERMINED. IN ADDITION, DURING THAT TIME THE PATIENT WAS UNABLE TO ACHIEVE COMPLETE SYMPTOMATIC RELIEF WITH VARIOUS TREATMENTS PROVIDED INCLUDING PAIN MEDICATIONS, ACUPUNCTURE, AND NERVE BLOCKS. ON (B)(6) 2012, THE PATIENT UNDERWENT A PROCEDURE FOR INSERTION OF A PERCUTANEOUS SPINAL CORD STIMULATOR. BY (B)(6), 2012 HER PAIN HAD DECREASED BY APPROXIMATELY 80%. ON (B)(6) 2012, THE PATIENT CONTINUED TO SHOW IMPROVEMENT IN HER LEFT LEG SYMPTOMS. NO ADDITIONAL RECORDS WERE PROVIDED." }, { "mdr_text_key": "11230155", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2010. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE PLANNED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." } ], "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": "" } ] }