{ "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": "2955842-2013-04831", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131008", "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": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "560466", "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": "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "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, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "102", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Low Blood Pressure/ Hypotension", "Laceration(s)", "Urinary Retention", "Urinary Tract Infection" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441242", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "21404949", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A UTERER INJURY DURING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "21267583", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION, AND REPAIR OF UMBILICAL HERNIA ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT, AND NOTES FROM SUBSEQUENT PROCEDURES. DURING SURGERY THE RIGHT URETER WAS INADVERTENTLY CUT BY THE SURGEON, NOTED IMMEDIATELY, AND SPATULATED AND REPAIRED WITH 5-0 VICRYL SUTURE AND STENTED. IT WAS NOTED THAT THE PATIENT HAD A VERY THICKENED COVERING ON THE ANTERIOR SURFACE OF THE ABDOMEN MAKING DISSECTION DIFFICULT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGEON COMPLETED A RADICAL PROSTATECTOMY WITH PLACEMENT OF TRANSPERINEAL STITCHES TO PROVED BLADDER TENSION, LYMPHADENECTOMY AND UMBILICAL HERNIA REPAIR WITHOUT ADDITIONAL COMPLICATION BEYOND THE INITIAL INADVERTENT SEVERING OF THE URETER. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2008 WITH THE RIGHT URETERAL STENT AND FOLEY CATHETER IN PLACE. ON (B)(6) 2008, THE PATIENT WAS SEEN FOR POORLY DISCHARGING FOLEY AND WAS FOUND TO HAVE A UTI. HIS FOLEY WAS REPLACED AND HE WAS PLACED ON CIPRO. ON (B)(4) 2008, PATIENT HAD FOLEY AND RIGHT URETERAL STENT REMOVED (NO RECORDS) ON (B)(6) 2008, PATIENT PRESENTED TO THE ED 7 DAYS AFTER FOLEY AND STENT REMOVAL WITH NO URINARY OUTPUT FOR 3 DAYS, LOSS OF APPETITE AND SEVERE LOW BLOOD PRESSURE. CT IMAGING SHOWED FLUID IN THE RETROPERITONEAL SPACE, AND PATIENT WAS ADMITTED FOR WORKUP. ON (B)(6) 2008 RETROGRADE PYELOGRAM SHOWED AN INTACT RIGHT URETER AND EXTRAVASATION FROM THE LEFT URETER. A LEFT NEPHROSTOMY TUBE WAS PLACED, BUT NO STENT WAS ABLE TO BE PLACED. ON (B)(6) 2008, PATIENT HAD CT GUIDED PLACEMENT OF AN ABDOMINAL DRAIN FOR A PERITONEAL ABSCESS AND WAS TREATED FOR SEPTICEMIA. ON (B)(6) 2008, AN OCCLUSION BALLOON WAS PLACED TO PREVENT FURTHER URINE LEAKAGE ON (B)(6) THE PATIENT WAS DISCHARGED HOME WITH NEPHROSTOMY TUBE AND OCCLUSION BALLOON. ON (B)(6) PATIENT UNDERWENT CYSTOSCOPY IN WHICH THE LEFT URETERAL ORIFICE COULD NOT BE LOCATED ON (B)(6) PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH EXTENSIVE DISSECTION OF RETROPERITONEAL SCAR TISSUE TO FREE LEFT SIDED URETER, INCISION AND DRAINAGE OF RESIDUAL LEFT PELVIC ABSCESS, TRANSURETHERAL URETEROSTOMY LEFT TO RIGHT TO RECONNECT THE LEFT URETER. ON (B)(6) 2008, THE PATIENT WAS ADMITTED WITH A GI BLEED WHICH WAS STABILIZED AFTER MULTIPLE TRANSFUSIONS BEFORE HIS DISCHARGE ON (B)(6) 2008. DURING HIS HOSPITALIZATION HIS NEPHROSTOMY TUBE AND FOLEY CATHETER WERE VISUALIZED WITH CONTRAST TO ENSURE PATENCY AND REMOVED. ON (B)(6) 2009, CYSTOSCOPY SHOWED THE ANASTOMOSIS WELL HEALED, AND THE URETERAL STENTS WERE REMOVED. ON (B)(6) 2009, PATIENT UNDERWENT IV UROGRAM WITH TOMOGRAPHY SHOWING THE LEFT URETER ANASTOMOSED TO THE RIGHT, MILD TRANSIENT HYDRONEPHROSIS. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." } ], "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": "" } ] }