{ "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": "2955842-2013-03459", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130910", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20081226", "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": "20130911", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "453287", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130910", "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": "IS 3000 A6.0P6", "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": "20250815", "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": "20130910", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "52 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Nausea", "Obstruction/Occlusion", "Abdominal Distention" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3340362", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "3869028", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS AND OPERATIVE REPORTS OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC AND PERIAORTIC LYMPHADENECTOMY AND SUFFERED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE ON (B)(6) 2008. BASED ON THE OPERATIVE REPORTS,THE DA VINCI PROCEDURE WAS WELL TOLERATED BY THE PATIENT AND THERE WAS NO MALFUNCTION THAT OCCURRED WITH THE DA VINCI SYSTEM AND OR INSTRUMENTS. POSTOPERATIVELY, THE PATIENT WAS NOTED TO HAVE ABDOMINAL DISTENTION AND NAUSEA AND WAS KEPT IN THE HOSPITAL AN EXTRA NIGHT AND WAS DISCHARGED ON (B)(6) 2008. ON (B)(6) 2008, THE PATIENT WAS SEEN IN THE ER FOR ABDOMINAL PAIN. CT SCAN SHOWED SMALL AMOUNT OF FLUID IN THE PELVIS WITH NO SIGNS OF PERITONITIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS SENT HOME AFTER ABOUT 4 DAYS OF HOSPITALIZATION. SHE RETURNED TO THE HOSPITAL ON (B)(6) 2009 WITH WORSENING SYMPTOMS AND A CT SCAN WAS PERFORMED. THE CT SCAN SHOWED DILATED LOOPS OF SMALL BOWEL WITH AIR FLUID LEVELS AND SOME PELVIC FLUID. ON (B)(6) 2009, THE PATIENT WENT INTO THE OPERATING ROOM FOR A CYSTOSCOPY, CYSTOGRAM, LEFT RETROGRADE PYELOGRAM AND URETEROSCOPY. DURING THE PROCEDURE THE URETER WAS FOUND TO BE OBSTRUCTED 2-3CM FROM THE BLADDER. A PERCUTANEOUS NEPHROSTOMY TUBE WAS LEFT IN PLACE. THE DECISION WAS MADE TO ALLOW THE PELVIC INFLAMMATION TO IMPROVE ON ANTIBIOTIC THERAPY AND TO REPEAT A CT SCAN ON (B)(6) 2009. THIS CT SCAN ON (B)(6) 2009 SHOWED DILATION OR THE INTRARENAL COLLECTING SYSTEMS AND URETER ON LEFT WITH ABRUPT CUT-OFF OVER MID URETER. BECAUSE OF THIS FINDING THE DECISION WAS MADE TO PROCEED WITH AN EXPLORATORY LAPAROTOMY WITH RE-IMPLANTATION OF THE LEFT URETER. THIS SURGICAL PROCEDURE WAS DONE ON (B)(6) 2009 WITHOUT ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. THE PATIENT WAD ADMITTED ON (B)(6) 2009 FOR RIGHT DISTAL INJURY REQUIRING RIGHT PERCUTANEOUS NEPHROSTOMY TUBE. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. THE PROCEDURE WAS TOLERATED WELL BY THE PATIENT. NO FURTHER CLINICAL INFORMATION HAS BEEN PROVIDED ABOUT THE PATIENT'S CURRENT STATUS." }, { "mdr_text_key": "11174331", "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, ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2008 AND NO MALFUNCTION WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. 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": "" } ] }