{ "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": "2955842-2013-04795", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121106", "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": "20131031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "560487", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "brand_name": "DA VINCI SI 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 A6.0P8", "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": "20250826", "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": "20131031", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "71", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Adhesion(s)", "Inflammation", "Nausea", "Tissue Damage", "Vomiting", "Obstruction/Occlusion", "Abdominal Cramps" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440441", "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": "3899123", "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 TOTAL LAPAROSCOPIC HYSTERECTOMY, MCCALL CULDOPLASTY, CYSTOSCOPY WITH CATHETERIZATION OF L URETER ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP OPERATIVE NOTES FROM SUBSEQUENT SURGERIES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION NAMELY OBSTRUCTION OF THE LEFT URETER IMMEDIATELY AFTER SURGERY, HOWEVER A STENT WAS PLACED TO KEEP THIS URETER OPEN. SEE THE DESCRIPTION BELOW. SUBSEQUENT HOSPITALIZATION AND PROCEDURES 3 WEEKS LATER WERE PERFORMED WHEN THE RIGHT URETER APPEARED TO HAVE BEEN DAMAGED AS WELL. ULTIMATELY THE RIGHT URETER HAD TO BE REIMPLANTED. ON (B)(6) 2012, THE PATIENT UNDERWENT A VINCI LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY, MCCALL CULDOPLASTY, CYSTOSCOPY WITH CATHETERIZATION OF LEFT URETER. FINDINGS: UTERUS 9 WEEKS SIZE. EXCERPTS: INDIGO CARMINE WAS GIVEN INTRAVENOUSLY AND CYSTOSCOPY WAS PERFORMED. IN APPROXIMATELY 12 MINUTES, POST INDIGO CARMINE INFUSION URINE EFFLUX WAS SEEN FROM THE RIGHT URETERAL ORIFICE. NO EFFLUX WAS SEEN FROM THE LEFT SIDE. IT WAS DECIDED TO CUT THE CULDOPLASTY STITCH WHICH WAS DONE CONCURRENTLY. STILL NO INDIGO CARMINE EFFLUX WAS SEEN FROM THE LEFT URETERAL ORIFICE. A 4 URETERAL CATHETER WITH A WHISTLE TIP WAS THEN EASILY PASSED THROUGH THE LEFT URETERAL ORIFICE UP TO THE LEVEL OF THE KIDNEY. NO RESISTANCE WAS NOTED AND THE PELVIS AND ABDOMEN WERE VISUALIZED LAPAROSCOPICALLY AND THERE WAS NO EVIDENCE OF EXTRAVASATION OF URINE. THERE WAS NO APPARENT INJURY TO THE URETER. FOLLOWING REMOVAL OF THE URETERAL CATHETER, VERY STRONG URETERAL JETS WERE SEEN BILATERALLY. REINSPECTION LAPAROSCOPICALLY REVEALED NO EVIDENCE OF EXTRAVASATION OF URINE OR INDIGO CARMINE INTO THE PELVIS OR ABDOMEN. ON (B)(6) 2012, THE PATIENT EXPERIENCED VOMITING STARTED WHICH STARTED AT 5:00PM. THE PATIENT HAS HAD MILD ABDOMINAL PAIN. THE PAIN WAS DESCRIBED AS LOCATED IN THE RIGHT LOWER QUADRANT (RLQ). CT: ABNORMAL STUDY. OBSTRUCTION OF THE RIGHT KIDNEY AT THE LEVEL OF THE RIGHT LOWER PELVIS. THIS MAY BE DUE TO BLOOD CLOT WITHIN THE RIGHT URETER OR POSSIBLY POSTOPERATIVE STRICTURE. ON (B)(6) 2012, PATIENT HAD A CONSULT WITH MD 17 DAYS STATUS POST LAPAROSCOPIC HYSTERECTOMY. THE PATIENT HAD A 24 HOUR HISTORY OF NAUSEA AND CRAMPY RIGHT LOWER QUADRANT ABDOMINAL PAIN. CT SCAN WAS ORDERED THAT DEMONSTRATES RIGHT URETERAL OBSTRUCTION. THERE WAS A DELAYED NEPHROGRAM ON THE RIGHT SIDE. THERE WAS HYDRONEPHROSIS AND HYDROURETER DOWN TO THE LEVEL OF THE DISTAL URETER. ON (B)(6) 2012, THE PATIENT HAD A CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAPHY, INTRAOPERATIVE FLUOROSCOPY WITH INTERPRETATION IMAGES, RIGHT URETEROSCOPY, DILATION OF DISTAL RIGHT URETER AND RIGHT DOUBLE PIGTAIL URETERAL STENT PLACEMENT. EXCERPT: DEMONSTRATED EXTRAVASATION OF CONTRAST IN THE DISTAL RIGHT URETER IN THE PELVIS OUTLINING THE BOWEL. ON (B)(6) 2013, PATIENT UNDERWENT A ROBOTIC-ASSISTED LAPAROSCOPIC RIGHT URETERONEOCYSTOSTOMY, PSOAS HITCH AND BOARI FLAP, DELEGATION OF RIGHT URETER, COMPLEX CYSTORRHAPHY, CYSTOSCOPY WITH DOUBLE PIGTAIL URETERAL STENT PLACEMENT, LAPAROSCOPIC LYSIS OF ADHESIONS. EXCERPTS: NEXT, THERE WERE NUMEROUS ADHESIONS IN THE ABDOMEN . THERE WAS SIGNIFICANT SCAR AND INFLAMMATION AS THE DISTAL URETER WAS MOBILIZED. PATIENT WAS OUT OF WORK FOR FOUR MONTHS BUT HAS RETURNED TO WORK AND WAS DOING WELL. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11098787", "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 COMPLAINT 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." } ], "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": "" } ] }