{ "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": "2955842-2016-00414", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160603", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20160317", "reprocessed_and_reused_flag": "N", "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": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "352495", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160603", "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": "HEALTH PROFESSIONAL", "model_number": "", "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": [ "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": "20250812", "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": "20160603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20160505", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5697781", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160505", "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": "46516651", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THE INITIAL REPORTER INFORMATION OF FDA VOLUNTARY REPORT MW5061216 IS BLANK. THE NAME OF THE HOSPITAL WHERE THE DA VINCI-ASSISTED HYSTERECTOMY WAS PERFORMED IS UNKNOWN. IN ADDITION, THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ISI OBTAINS ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE AND ALLEGEDLY SUSTAINED A 2 INCH LACERATION. HOWEVER, AT THIS TIME, THE CAUSE AND SEVERITY OF THE ALLEGED OPERATIVE COMPLICATION IS UNKNOWN. IN ADDITION, THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S OPERATIVE COMPLICATION." }, { "mdr_text_key": "46516652", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5061216 WITH THE FOLLOWING EVENT DESCRIPTION: UNDERWENT HYSTERECTOMY WITH DAVINCI ROBOT AND EXPERIENCED A 2 INCH LACERATION AT (B)(6) HOSPITAL IN (B)(6) PERFORMED BY DR. (B)(6). HIGH RISK FOR THIS PROCEDURE BECAUSE HAD A C-SECTION SEVERAL YEARS AGO. KEPT OVERNIGHT. QUESTION AS TO WHY DAVINCI ROBOT WAS USED WHEN POSSIBLY MORE DELICATE TECHNIQUE SHOULD HAVE BEEN USED RATHER THAN THE DAVINCI ROBOT." } ], "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": "" } ] }