{ "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 REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP NOTES AND OPERATIVE REPORTS. 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. ROBOTIC PROSTATECTOMY ON (B)(6) 2012. ON (B)(6) 2012, HE DEVELOPED A FISTULA BETWEEN RECTUM AND URETHRA. VISITS TO PHYSICIAN NOTE CONSERVATIVE TREATMENT WAS TRIED INITIALLY. ON (B)(6) 2012, HE WAS ADMITTED AND UNDERWENT A TRANSANAL RECTOURETHRAL FISTULA REPAIR AND A LAPAROSCOPIC DIVERTING COLOSTOMY. FOLLOWING SURGERY HAD POSSIBLE PERI-ABDOMINAL INFECTION AND WAS MAINTAINED ON IV ANTIBIOTICS. ON (B)(6) 2012, HE HAD TO UNDERGO A SECOND ATTEMPTED FISTULA REPAIR. ULTIMATELY DISCHARGED, AND HAD SUBSEQUENT REVERSAL OF COLOSTOMY." }, { "mdr_text_key": "11217151", "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 OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. 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 S SURGICAL PROCEDURE. THIS TYPE OF INJURY FOLLOWING RADICAL PROSTATECTOMY IS A WELL KNOWN RISK OF THIS OPERATION. THERE MAY BE SOME COMPONENT OF ADDITIONAL RISK DUE HIS VENTILATION PROBLEMS INTRAOPERATIVELY." } ], "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": "03/10/2015" } ] }