{ "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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SYS., INSTRUMENTS, & ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fainting", "Hemorrhage/Blood Loss/Bleeding", "Pain" ] } ], "distributor_city": "", "date_report": "20130110", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2576917", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120419", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "2648777", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI SI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, AT (B)(6) WAS FOUND POSTED ON THE (B)(6) BY INTUITIVE SURGICAL ON (B)(6) 2012. AFTER TRYING OTHER MEASURES FAILED TO STOP THE BLEEDING AND PAIN OF FIBROIDS A HYSTERECTOMY WAS NECESSARY. THE PROCEDURE WAS SIMPLE AND SCARING AND BLEEDING WERE MINIMAL. THE FIRST 2 WEEKS WENT BY SMOOTHLY AND THE PAIN WAS GONE WITHIN THE FIRST FEW DAYS. THE BIGGEST INCONVENIENCE WAS NOT BEING ABLE TO DRIVE FOR 2 WEEKS. THEN I HAD A TURN FOR THE WORSE. THE DAY AFTER MY 2 WEEK FOLLOW UP APPOINTMENT I STARTED TO BLEED HEAVILY. I WAS SOAKING A PAD AN HOUR. THE ON-CALL SURGEON DID NOT SEEM TO THINK IT WAS SERIOUS AND ADVISED TO WAIT 4 HOURS AND GO TO THE ER IF IT CONTINUED. THE ER DOCTOR DID AND PHYSICAL EXAM AND DID NOT SEE ANY SIGNS OF A RUPTURE. HE TOO CONSULTED THE ON-CALL SURGEON WHO SUGGESTED I BE RELEASED AND TO CONTACT MY DOCTOR THE FOLLOWING MORNING. ON THE WAY HOME FROM THE ER I BEGAN TO EXPERIENCE INTENSE PAIN IN MY LOWER BACK AND CRAMPS EQUIVALENT TO CONTRACTIONS. I FELT A HUGE GUSH OF BLOOD AND FAINTED. THE AMBULANCE WAS CALLED AND I WAS TAKEN BACK TO THE ER BY THIS TIME I HAD BEEN BLEEDING FOR 8 HOURS AND LOST 2 PINTS OF BLOOD. AFTER AN ULTRA SOUND IT WAS DECIDED THAT I WOULD NEED TO UNDERGO A SECOND SURGERY. THE SUTURES HAD DISSOLVED AND THE CUFF HAD OPENED CAUSING THE BLEEDING. THIS COMPLICATION ALSO CAUSED ME TO BECOME ANEMIC, BUT FORTUNATELY I DID NOT HAVE TO UNDERGO A BLOOD TRANSFUSION. ITS NOW 7 WEEKS. SINCE THE INITIAL PROCEDURE AND ALL IS WELL. MY DOCTOR IN HIS 20 YEARS EXPERIENCE HAD NEVER SEEN THIS COMPLICATION. DURING MY INITIAL 2 WEEK RECOVERY I DID ALL AS INSTRUCTED. I WAS EVEN READY TO GO BACK TO WORK THE VERY NEXT DAY WHEN THE BLEEDING STARTED. I LOOK FORWARD TO NO LONGER HAVING PAIN OR DISCOMFORT FROM THE FIBROIDS OR MENSTRUATION." }, { "mdr_text_key": "10423957", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "9861783", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED BY THE PATIENT, IT IS INDETERMINABLE IF THE DA VINCI SI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE POST SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. ISI HAS CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "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": "01/10/2013" } ] }