{ "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": "2955842-2010-00084", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20100304", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100205", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110906", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100304", "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 A6.0P3", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20100209", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Intermittent Shock/Stimulation" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20100304", "sequence_number_treatment": [ "DA VINCI SI SYSTEM, INSTRUMENTS, ACCESSORIES, ESU" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20130122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1622530", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20100205", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Repair" ], "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": "10446025", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "17887956", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE PHYSICIAN AT THE SURGEON SIDE CONSOLE INTERMITTENTLY FELT A SHOCK IN HIS FINGERTIPS FROM THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SURGEON SWITCHED TO THE SITE'S SECOND SURGEON SIDE CONSOLE TO COMPLETE THE PLANNED PROCEDURE AND NO FURTHER OCCURRENCES OF SHOCK WERE REPORTED. NO HARM TO THE PHYSICIAN OR PATIENT WAS REPORTED." }, { "mdr_text_key": "17914457", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PER THE CUSTOMER REPORTED COMPLAINT, THE INVESTIGATION CONDUCTED BY THE ISI FIELD SERVICE ENGINEER FOUND THAT THE SYSTEM PASSED ELECTRICAL SAFETY TESTING AND ALL VALUES PERFORMED TO SPECIFICATION, HOWEVER, AS A PRECAUTION, THE RIGHT MASTER TOOL MANIPULATOR (MTMR) WAS REPLACED. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDES THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). AN INTERVIEW WITH THE SURGEON CONDUCTED BY AN ISI REPRESENTATIVE ON MARCH 2, 2010, FOUND THAT THE SURGEON WAS WEARING STANDARD SCRUBS AND SHOES DURING THE PROCEDURE AS WELL AS THE SAME CHAIR THAT HAS BEEN PREVIOUSLY USED IN OTHER DA VINCI CASES. HE STATED THAT CAUTERY WAS IN USE AND THAT THE PATIENT WAS GROUNDED AS PER THE HOSPITAL'S NORMAL PRACTICE. HE WAS UNABLE TO CONFIRM THAT ANYTHING HAD CHANGED IN THE OPERATING ROOM ENVIRONMENT FROM PRIOR CASES. THE MTMR WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION, HOWEVER, THE SHOCK EXPERIENCED BY THE CUSTOMER COULD NOT BE DUPLICATED. AS OF MARCH 3, 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL OR BY THIS SURGEON." } ], "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": "01/22/2013" } ] }