{ "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": "2955842-2013-03147", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120209", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409417", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": "IS3000 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": [ "Difficult To Position", "Malposition of Device", "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20130823", "sequence_number_treatment": [ "DAV SI SURG. SYSTEM INSTRUMENTS, ESU & ACCESS." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "42 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Nausea", "Pain", "Obstruction/Occlusion", "No Code Available" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305558", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "3591123", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON JULY 25TH, 2013 INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI CYSTIC RIGHT SALPINGO OOPHORECTOMY AND CYSTECTOMY PROCEDURE ON (B)(6) 2012. IN LATE (B)(6) 2012, A CT SCAN WAS PERFORMED SHOWED THAT THE PATIENT HAD A COMPLEX CYSTIC LESION ON HER RIGHT OVARY. IN LATE (B)(6) 2012 THE PATIENT EXPERIENCED NAUSEA AND BACK PAIN. A CT SCAN WAS ORDERED, WHICH SHOWED A VERY MARKED HYDRONEPHROSIS. THE SURGEON NOTED THAT THE PATIENT'S URETER WAS VERY DILATED DOWN TO THE PELVIC BRIM IN THE REGION WHERE THE PRIOR OVARIAN CYST WAS. THE SURGEON MADE THE DECISION TO PROCEED WITH A CYSTOSCOPY RIGHT RETROGRADE PYELOGRAM AND POSSIBLE STENT INSERTION. ON (B)(6) 2012 THE PATIENT UNDERWENT A RIGHT RETROGRADE PYELOGRAM URETEROSCOPY AND INSERTION OF A DOUBLE J STENT. THE URETEROSCOPY DEMONSTRATED A PROBABLE SCARRED AREA WITH A SMALL CALIBER. THE STENT WAS PLACED WITH SOME DIFFICULTY. DURING THE PROCEDURE, THE URETEROSCOPY ALSO SHOWED A HIGH GRADE OBSTRUCTION WITH A PALE AREA OF THE URETER, WHICH WAS FELT TO REPRESENT AN AREA OF ISCHEMIA. A FOLLOW UP CT SCAN WAS PERFORMED ON (B)(6) 2012 AND SHOWED HYDRONEPHROSIS WITH A MALPOSITIONED URETERAL STENT. SECONDARY TO THE RECURRENT HYDRONEPHROSIS, THE DECISION WAS MADE TO PROCEED WITH THE PLACEMENT OF A NEPHROSTOMY TUBE. ON (B)(6) 2012 A NEPHROSTOMY TUBE WAS PLACED SUCCESSFULLY. THE PATIENT UNDERWENT URETERAL REIMPLANTATION SURGERY FOR AN OBSTRUCTED URETER ON (B)(6) 2012. THE PATIENT WAS DISCHARGED ON (B)(6) 2012 ON ANTIBIOTICS AND PAIN MEDICATION. ON (B)(6) 2012 THE PATIENT HAD HER NEPHROSTOMY TUBE REMOVED. ON (B)(6) 2012 A \"LYSTOSCOPY\" WAS PERFORMED AND THE PATIENT'S URETERAL STENT WAS REMOVED. ON (B)(6) 2012, THE PATIENT BEGAN HAVING PROBLEMS WITH FLANK PAIN. A RENAL AND BLADDER ULTRASOUND PERFORMED ON (B)(6) 2012 THAT SHOWED HYDRONEPHROSIS IN THE PATIENT'S RIGHT KIDNEY, SUGGESTING A RECURRENT OBSTRUCTION OF THE RIGHT URETER. A CT-SCAN WAS PERFORMED, WHICH SHOWED A HYDROURETERONEPHROSIS DOWN TO HER ANASTOMOSIS OF THE RIGHT SIDE, THUS INDICATING THAT THE URETER WAS NOT DRAINING WELL. ON (B)(6) 2012, THE SURGEON PROCEEDED WITH CYSTOSCOPY AND URETERAL STENT PLACEMENT THAT REMAINED IN THE PATIENT UNTIL (B)(6) 2012, AT WHICH TIME SHE HAD ANOTHER CYSTOSCOPY PERFORMED WITH REMOVAL OF THE STENT. THE PATIENT CONTINUED TO HAVE SOME SYMPTOMS AND MADE THE DECISION TO BE EVALUATED AT ANOTHER HOSPITAL. DURING THE PATIENT'S EVALUATION AT THE NEW FACILITY IT WAS DISCOVERED THAT HER RENAL FUNCTION WAS SEVERELY COMPROMISED FROM THE URETERAL INJURY. IT WAS RECOMMENDED TO THE PATIENT, THAT SHE HAVE HER RIGHT KIDNEY REMOVED. ON (B)(6) 2012 THE PATIENT UNDERWENT REMOVAL OF HER RIGHT KIDNEY. THE SURGERY WAS PERFORMED WITHOUT COMPLICATION." }, { "mdr_text_key": "11012703", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED IN THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES 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 INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT HAD POST OPERATIVE COMPLICATIONS AFTER A DA VINCI SI CYSTIC RIGHT SALPINGO OOPHORECTOMY AND CYSTECTOMY PROCEDURE." } ], "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": "" } ] }