{ "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": "2955842-2013-04307", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131010", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "517711", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131010", "brand_name": "DA VINCI 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": "0", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20131010", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20130913", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3405356", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131118", "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": "3918465", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LETTER FROM THE REPORTER. ACCORDING TO THE LETTER, THE REPORTER WAS IN THE PROCESS OF WRITING A CASE REPORT ON A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC SURGERY (BY ANOTHER PHYSICIAN) AND SUFFERED WHAT APPEARS TO BE AN ELECTRICAL INJURY. DETAILS RELATED TO THE DA VINCI SURGICAL PROCEDURE WERE NOT PROVIDED. ISI ATTEMPTED TO CONTACT THE REPORTER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "11152635", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DETAILS REGARDING THE REPORTED PROCEDURE ARE LIMITED; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. BASED ON THE REPORTED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT THAT UNDERWENT A DA VINCI SURGICAL PROCEDURE APPEARED TO HAVE SUFFERED AN ELECTRICAL INJURY." }, { "mdr_text_key": "11538550", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 11/18/2013, THE INITIAL REPORTER EMAILED INTUITIVE SURGICAL, INC. (ISI) A CASE REPORT THAT HE HAS AUTHORED TITLED, DIFFUSE ELECTRICAL INJURY AS A MECHANISM OF POST-OPERATIVE INJURY IN ROBOTIC SURGERY. THE ABSTRACT SECTION NOTED THE FOLLOWING: A PATIENT PRESENTS WITH NEURO-SOMATIC SYMPTOMS 17 DAYS AFTER WHAT APPEARS TO BE AN UNEVENTFUL DAVINCI ROBOTIC MYOMECTOMY BY AN EXPERT SURGEON. MULTIPLE HOSPITALIZATIONS, CONSULTATIONS, AND TESTS FAILED TO REVEAL THE ETIOLOGY. THE DAVINCI ELECTRICAL LEAKAGE PROBLEM MAY HAVE CAUSED A RARE, AS OF YET FULLY ELUCIDATED, COMPLICATION KNOWN AS DIFFUSE ELECTRICAL INJURY (DEI). DEI APPEARS TO BE A REASONABLE, BIOLOGICALLY PLAUSIBLE EXPLANATION FOR THE PATIENT'S SYMPTOMS. THE CASE REPORT SECTION NOTED THE FOLLOWING: ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT LAPAROSCOPY FOR RIGHT LOWER QUADRANT COMFORT, CONFIRMING THE PRESENCE OF A FIBROID PREVIOUSLY VISUALIZED ON SONOGRAPHY. A FEW WEEKS LATER, THE PATIENT UNDERWENT A ROBOTIC MYOMECTOMY. TEN DAYS POST-OPERATIVELY, THE PATIENT WENT TO AN URGENT CLINIC WITH LOWER ABDOMINAL PAIN. SHE WAS DIAGNOSED WITH AN INFECTION, TREATED WITH BACTRIM, AND DISCHARGED FROM THE HOSPITAL'S EMERGENCY DEPARTMENT TWO DAYS LATER. SIXTEEN DAYS POST-OPERATIVELY, THE PATIENT WOKE UP WITH GENERALIZED, SHARP, CONSISTENT, THROBBING, MUSCULAR PAIN THAT WAS DESCRIBED AS 'EVERYWHERE'-ARMS, LEGS, AND BACK, NECK, SHOULDERS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS DIAGNOSED WITH ASEPTIC MENINGITIS FROM THE BACTRIM. WHEN THE PATIENT WAS DISCHARGED HOME, SHE WAS STILL HAVING INTENSE PAIN AND TIGHTNESS IN THE HECK AND SHOULDERS. THE DAY AFTER DISCHARGE, THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL FOR 7 DAYS FOR PAIN CONTROL. WHEN SHE WAS DISCHARGED, THE PATIENT WAS STILL EXPERIENCING GENERALIZED PAIN, DEVELOPED A NEW COUGH THAT WAS TRIGGERED BY EATING, DRINKING, AND TALKING. ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED PERIPHERAL NERVE BIOPSIES OF THE LEFT THIGH, CALF, AND FOOT, WHICH SHOWED SMALL FIBER NEUROPATHY. THE PATIENT'S PAIN IS CONSTANT AND WORSE AT NIGHT, CONCENTRATED IN FINGERS, TOES, AND LEGS BELOW THE KNEES. THE PATIENT ALSO HAS RANDOM MUSCLE SPASMS, TROUBLE WALKING, AND HER SKIN HURTS TO BE TOUCHED. A MRI SHOWED L4,5 HERNIATION, THE PATIENT'S PELVIC SONOGRAM WAS NORMAL, AND A CONSULTATION WITH A PULMONOLOGIST YIELDED A DIAGNOSIS OF UPPER AIRWAY COUGH SYNDROME AND POSSIBLE POSTNASAL DRIP. BASED ON THE ADDITIONAL INFORMATION, THIS COMPLAINT REMAINS AS AN ADVERSE EVENT SINCE INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT." } ], "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": "01/28/2014" } ] }