{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-04893", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110215", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "563239", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "brand_name": "DA VINCI S SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P7", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20131101", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "40 YR", "patient_sex": "", "patient_weight": "77", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Tissue Damage", "No Code Available" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3443600", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "19469966", "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. NO PREVIOUS COMPLAINTS WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED POST -SURGICAL COMPLICATIONS." }, { "mdr_text_key": "19295916", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY; LYSIS OF PELVIC ADHESIONS FOR MENORRHAGIA, FIBROID UTERUS, RIGHT OVARIAN CYST AND PELVIC PAIN ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. PER OPERATIVE REPORT, ON (B)(6) 2011, THE PATIENT HAD A LARGE MULTILOBULAR FIBROID UTERUS. NO ADNEXAL MASSES. UTERUS APPX 10 EM. LEFT OVARIAN FALLOPIAN TUBE APPEARED NORMAL; THE RIGHT OVARY SOMEWHAT ADHERENT TO THE RIGHT PELVIC SIDE WALL, BUT NO EVIDENCE OF OVARIAN CYSTS. THERE WAS SOME SCARRING OF THE RIGHT OVARY ON THE RIGHT SIDE. LYSIS OF THE ADHESIONS TO FREE UP TO RIGHT OVARY AND PELVIC SIDE WALL. URETER WAS IDENTIFIED. ON (B)(6) 2011, RADIOLOGY FINAL REPORT NOTES INDICATE A CT SCAN ABDOMEN AND PELVIS WITH CONTRAST WAS PERFORMED. FLUID COLLECTION WITH AIR MIXED WITHIN IT IN THE DEPENDENT PORTION OF THE PELVIS IS LIKELY TO REPRESENT EITHER HEMATOMA OR ABSCESS. ON (B)(6) 2011, RADIOLOGY FINAL REPORT NOTES, INDICATE CT SCAN OF ABDOMEN WITHOUT INTRAVENOUS CONTRAST AND CT SCAN OF PELVIS WITHOUT INTRAVENOUS CONTRAST WAS PERFORMED. PELVIC FLUID COLLECTION IN THE SETTING OF RECENT HYSTERECTOMY, LEADING DIFFERENTIAL CONSIDERATIONS INCLUDE HEMATOMA OR ABSCESS. ON (B)(6) 2011, RADIOLOGY FINAL REPORT NOTES INDICATE CT SCAN OF ABDOMEN WITH INTRAVENOUS CONTRAST AND CT SCAN OF PELVIS WITH INTRAVENOUS CONTRAST. FINDINGS WAS THAT THE DISTAL RIGHT URETER INJURY WITH EXTRALUMINAL EXTRAVASATION OF CONTRAST MATERIAL. THERE IS AN INDETERMINATE LESION WITHIN THE LIVER. ON (B)(6) 2011, OPERATIVE REPORT MENTIONS CYSTOSCOPY, RETROGRADE PYELOGRAM UNDER FLUOROSCOPY, RIGHT URETEROSCOPY. SURGEON COULD NOT PLACE GUIDEWIRE AND WILL NEED NEPHROSTOMY TUBE. ON (B)(6) 2011, RADIOLOGY FINAL REPORT STATES, AN ULTRASOUND AND FLUOROSCOPICALLY GUIDED PLACEMENT OF RIGHT PERCUTANEOUS NEPHROSTOMY TUBE. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. OPERATIVE REPORT INDICATES CYSTOSCOPY PYELOGRAM & NEPHROSTOGRAM. THERE WAS EXTRAVASATION FROM THE RIGHT URETER IN THE VERY DISTAL PORTION. SEVERAL DEFECTS WERE PRESENT BETWEEN THE 2 ENDS OF THE URETER. RADIOLOGY FINAL REPORT- BILATERAL RETROGRADE PYELOGRAM. NEGATIVE LEFT RETROGRADE PYELOGRAM. ABNORMAL RIGHT RETROGRADE AND ANTEGRADE HOLOGRAM WITH EXTRAVASATION OF URINE FROM THE DISTAL RIGHT URETER NEAR THE BLADDER. ON (B)(6) 2011, PATIENT WENT TO THE ER FOR RIGHT FLANK PAIN. ON (B)(6) 2011, RADIOLOGY FINAL REPORT, INDICATED A CT SCAN OF THE ABDOMEN PELVIS WAS PERFORMED. EXTRAVASATION OF THE CONTRAST ON THE RIGHT SIDE WHICH APPEARS TO EXTEND INTO THE REGION OF THE WALL OF THE VAGINA. THIS SUGGESTS THE RIGHT DISTAL URETER IS BEEN DISRUPTED AT THIS POINT. ULTRASOUND SUGGESTED NEPHROSTOMY TUBE IN PLACE ON THE RIGHT WITH NO EVIDENCE OF OBSTRUCTION OF THE RIGHT UPPER COLLECTING SYSTEM. ON (B)(6) 2011, LAPAROTOMY WITH RIGHT URETERAL REIMPLANTATION FOR RIGHT URETERAL OBSTRUCTION. DURING SURGERY IT WAS NOTED THERE HAD BEEN A SLIGHT TEAR IN THE SEROMUSCULAR LAYERS OF THE POSTERIOR DOME OF THE BLADDER, WHICH WAS REPAIRED. 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. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }