{ "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": "2955842-2013-00828", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130314", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20130212", "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": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130315", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "107842", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130314", "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 S A5.1P8", "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": "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": "20130314", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20130212", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3005215", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130212", "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": "10678521", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) ASSIGNED TO THE SITE. THE CSR INDICATED THAT HE SPOKE TO THE (B)(6) AT THE HOSPITAL. PER THE CSR, THE (B)(6) INDICATED TO HIM THAT THE DA VINCI S HYSTERECTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED AND THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE CSR INDICATED THAT THE OR DIRECTOR INDICATED TO HIM THAT THE PATIENT DEVELOPED UNSPECIFIED POST-OPERATIVE COMPLICATIONS; HOWEVER, THE (B)(6) WAS UNABLE TO PROVIDE THE DATE/TIME THAT THE PATIENT BEGAN TO EXPERIENCE THE POST-OPERATIVE COMPLICATIONS. THE CSR INDICATED THAT THE OR DIRECTOR INDICATED TO HIM THAT THE DATE OF THE SURGICAL PROCEDURE IS UNKNOWN; HOWEVER, NO MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT THE (B)(6) INDICATED TO HIM THAT THE PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE AT THE HOSPITAL AND IT WAS DISCOVERED THAT SUTURES WERE STUCK TO THE PATIENT'S LARGE COLON AND THAT UPON REMOVAL OF THE SUTURES, A PERFORATION OF THE PATIENT'S LARGE COLON WAS DISCOVERED AND THAT THE AFFECTED AREA WAS REPAIRED. THE CSR INDICATED THAT THE (B)(6) WAS UNABLE TO PROVIDE HIM WITH INFORMATION REGARDING THE CURRENT STATUS OF THE PATIENT. BASED ON THE INFORMATION PROVIDED BY THE SITE, IT IS INDETERMINABLE AS TO WHAT CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. INTUITIVE SURGICAL HAS CONTINUED TO REQUEST ADDITIONAL INFORMATION FROM THE SITE REGARDING THIS EVENT; HOWEVER, AS OF THE DATE OF THIS REPORT NO ADDITIONAL INFORMATION OR RESPONSE HAS BEEN PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "3382767", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A DA VINCI S HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT SUSTAINED RECTAL/COLON INJURIES, WHICH REQUIRED THE PATIENT TO UNDERGO ADDITIONAL SURGICAL PROCEDURES." } ], "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": "" } ] }