{ "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": "2955842-2013-04998", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131102", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110816", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "565163", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131102", "brand_name": "DA VINCI S 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": "IS2000 A5.1P7", "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": "WA", "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": "20131102", "sequence_number_treatment": [ "DAV S SURG SYS INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "40 YR", "patient_sex": "", "patient_weight": "76", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Bacterial Infection", "Fungal Infection" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444436", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "18727080", "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 WHO UNDERWENT A DA VINCI S HYSTERECTOMY ON (B)(6) 2011 FOR ENDOMETRIOSIS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, NAMELY A TROCAR INJURY TO THE SMALL INTESTINE. IT WAS REPAIRED BY A GENERAL SURGEON AT THE TIME OF THE PRIMARY OPERATION; HOWEVER THE PATIENT'S CONDITION WORSENED. ON (B)(6) 2011 THE PATIENT RETURNED TO SURGERY FOR A LAPAROTOMY WHERE A SECOND AREA OF PERFORATION WAS FOUND. HER RECOVERY WAS COMPLICATED BY RECURRENT BOUTS OF BACTERIAL AND FUNGAL INFECTION. SHE HAD TO RETURN FOR A SECOND LAPAROTOMY ON (B)(6) 2011 FOR LYSIS OF ADHESIONS. AT ONE POINT A TRACHEOSTOMY WAS REQUIRED AFTER PROLONGED INTUBATION. HER LAST HOSPITAL DISCHARGE WAS ON (B)(6) 2011 AFTER 65 DAYS IN THE HOSPITAL." }, { "mdr_text_key": "18561886", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS PATIENT SUFFERED A DIRECT ENTRY TROCAR INJURY TO HER BOWEL THAT WENT UNRECOGNIZED IN PART FOR A TIME AND WAS COMPLICATED BY ENTERIC CONTAMINATION. THE CONSEQUENCES OF PERITONITIS INCLUDING SEPSIS, ARDS WERE EXPERIENCED BY THE PATIENT ALL AS A RESULT OF THE INITIAL PLACEMENT OF A LAPAROSCOPIC TROCAR. THIS PRIMARY STEP IN LAPAROSCOPIC SURGERY IS PERFORMED USING THE DA VINCI TOOLS, BUT IS NOT STRICTLY PART OF THE ROBOTIC PORTION OF THE OPERATION. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED WAS INJURED DURING A DA VINCI SURGICAL PROCEDURE." } ], "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": "" } ] }