{ "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 S TOTAL HYSTERECTOMY FOR FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES MEDICAL REPORTS, OPERATIVE NOTES, AND EXAMINATIONS FOR FURTHER CARE. THERE WAS NOT AN INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY .THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION . ON (B)(6) 2012 THE PATIENT PRESENTED WITH FLUID LEAKING FROM VAGINA. A RIGHT URETEROVAGINAL FISTULA WAS DIAGNOSED. SHE UNDERWENT A CYSTOSCOPY, RETROGRADE PYELOGRAM AND RIGHT URETERAL SENT PLACEMENT. SHE WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, SHE PRESENTED WITH COMPLAINTS OF RIGHT SIDED FLANK PAIN. CT UROGRAM SHOWED MILD R HYDRONEPHROSIS ON (B)(6) 2012, THE PATIENT HAD A R URETERAL RE-IMPLANTATION. SHE HAS HAD SUBSEQUENT VISITS FOR CONTINUED R FLANK PAIN AND A STENT WAS PLACED IN THE R URETER." }, { "mdr_text_key": "11377605", "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 SURGICAL PROCEDURE. THIS PATIENT UNDERWENT A SIMPLE BUT TECHNICALLY DIFFICULT HYSTERECTOMY FOR A VERY IRREGULAR AND LARGE MYOMATOUS UTERUS. THIS TYPE OF URETERAL INJURY IS A KNOWN RISK FACTORS FOR THIS TYPE OF SURGERY." } ], "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": "" } ] }