{ "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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THE PROVIDED INFORMATION ALLEGES THAT THE PATIENT SUSTAINED INJURIES INCLUDING BLOOD VESSEL AND NERVE DAMAGE AND SEVERE INCONTINENCE. THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY REPORTED. NO OTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11129491", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROSTATECTOMY PROCEDURE." }, { "mdr_text_key": "24205645", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON OCTOBER 4, 2013 INTUITIVE SURGICAL RECEIVED ADDITIONAL INFORMATION AS PART OF A LEGAL DISPUTE REGARDING A PATIENT THAT UNDERWENT A DA VINCI ROBOTIC PROSTATECTOMY PLUS ADHESIOLYSIS INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES PATHOLOGY REPORT, AND OPERATIVE ANESTHESIA RECORD. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION." } ], "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": "11/02/2013" } ] }