{ "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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RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WITH HISTORY OF IRREGULAR MENSTRUAL PERIODS AND AN ENLARGED FIBROID UTERUS WHO EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY. ACCORDING TO THE OPERATIVE REPORT FOR (B)(6) 2012, DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGECTOMY WAS PERFORMED FOLLOWED BY CYSTOSCOPY. INDIGO CARMINE WAS ADMINISTERED INTRAVENOUSLY; BLUE DYE WAS VISUALIZED COMING FROM THE RIGHT URETERAL ORIFICE BUT NOT FROM THE LEFT. THE UROLOGIST WAS CONSULTED AND HE WAS ABLE TO PASS A DOUBLE-J STENT UP THE LEFT URETER. THE STENT WAS INTENDED TO BE IN PLACE FOR SIX WEEKS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2013 THE PATIENT UNDERWENT A CYSTOSCOPY, LEFT DOUBLE-J STENT REMOVAL, LEFT RETROGRADE PYELOGRAM, RIGHT RETROGRADE PYELOGRAM, LEFT DISTAL SEMIRIGID URETEROSCOPY, BALLOON DILATION LEFT URETEROVESICAL JUNCTION (UVJ), AND LEFT DOUBLE-J STENT PLACEMENT. THE PATIENT TOLERATED THE PROCEDURES WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN A STABLE CONDITION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO INTUITIVE SURGICAL INC." }, { "mdr_text_key": "11286036", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY." } ], "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": "" } ] }