{ "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": "2955842-2010-00340", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20100728", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "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": "20100729", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100728", "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": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P4", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20100728", "sequence_number_treatment": [ "DA VINCI SI SYS INSTRUMENTS, ACCESSORIES AND ESU" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Nerve Damage" ] } ], "distributor_city": "", "date_report": "20100629", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1773407", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20100629", "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": "1566906", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNSPECIFIED NERVE DAMAGE." }, { "mdr_text_key": "8732109", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON JUNE 29, 2010, THE SITE'S ROBOTICS COORDINATOR (B)(4) STATED THAT AN ANESTHESIOLOGIST (DR. (B)(6) NOTIFIED HER THAT SHE WAS POSITIONING PATIENTS INCORRECTLY FOR ROBOTIC ASSISTED PROCEDURES, RESULTING IN MULTIPLE PATIENTS EXPERIENCING POST PROCEDURE NERVE DAMAGE. MS. (B)(4) STATED THAT SHE HAS BEEN POSITIONING PATIENTS IN THE SAME MANNER AND HAS NOT HAD ANY PREVIOUS PROBLEMS. THE ISI CLINICAL SALES REPRESENTATIVE BELIEVES THAT MS. (B)(4) IS POSITIONING PATIENT'S IN AN APPROPRIATE MANNER BASED ON WHAT SHE HAS OBSERVED. - ON JULY 13, 2010, MS. (B)(4) STATED THAT SHE HAS NOT HAD ANY FURTHER FOLLOW UP FROM THE DR. (B)(6) AFTER MULTIPLE REQUESTS TO HIM FOR MORE INFORMATION. THE ISI CLINICAL SALES REPRESENTATIVE HAS ALSO ATTEMPTED TO REACH DR. (B)(6) WITHOUT SUCCESS. - ON JULY 20, 2010, MS. (B)(4) REQUESTED THAT ISI FOLLOW UP WITH DR. (B)(6) DIRECTLY AS SHE HAS NO FURTHER INFORMATION. - ON JULY 22, 2010, AN URGENT MESSAGE WAS LEFT FOR DR.(B)(6) REQUESTING MORE INFORMATION ABOUT THESE EVENTS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE SITE RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. AS OF JULY 23, 2010, NO FURTHER OCCURRENCES OF THESE EVENTS HAVE BEEN REPORTED BY THIS SITE. BASED ON THE INFORMATION PROVIDED BY THE SITE IT WAS DETERMINED THAT THE DA VINCI SI SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT WOULD HAVE LED OR CONTRIBUTED TO THE PATIENT'S INJURY. PLEASE ALSO SEE RELATED MANUFACTURER MEDWATCH REPORTS: 2955842-2010-00341 2955842-2010-00342 2955842-2010-00343" } ], "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": "" } ] }