{ "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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A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AT THIS TIME, THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI S SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT ALLEGED THAT A PATIENT, WHO UNDERWENT A DA VINCI SURGICAL PROCEDURE, SUSTAINED POST-OPERATIVE COMPLICATIONS AND REQUIRED A SECONDARY SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE DA VINCI S SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY." }, { "mdr_text_key": "16680286", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) ON (B)(6) 2010. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT EXPERIENCED COMPLICATIONS INCLUDING BUT NOT LIMITED TO SEVERE BOWEL INJURIES, EXCESSIVE BLEEDING, INJURY TO THE SIGMOID COLON AND INTESTINES, PLUS POST OPERATIVE COMPLICATIONS AND INFECTION INCLUDING PAIN, BLEEDING, FEVER, CHILLS, NAUSEA AND OTHER SYMPTOMS INDICATIVE OF A BOWEL ISSUE, INFECTION AND COMPLICATIONS AS EARLY AS HER POST-OPERATIVE VISIT ON (B)(6) 2010, WITH A DOCTOR RESULTING IN FURTHER SUFFERING AND COMPLICATIONS TO THE PLAINTIFF INCLUDING BUT NOT LIMITED TO CONSTIPATION, UPPER ABDOMINAL PAIN, VOMITING, AN ABSCESS, A MASSIVE ABDOMINAL INFECTION AND THE NEED FOR FURTHER SURGERY INCLUDING A BOWEL RESECTION ON (B)(6) 2013." } ], "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": "" } ] }