{ "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": "2955842-2015-00919", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20150618", "manufacturer_address_2": "", "pma_pmn_number": "", "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", "Consumer", "CONSUMER", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150618", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "397410", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150618", "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": "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20150618", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Unspecified Infection", "Pain", "Injury", "Numbness" ] } ], "distributor_city": "", "date_report": "20150603", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4853915", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150603", "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": "16355354", "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 OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. ON (B)(4) 2015, ISI CONTACTED THE PATIENT DIRECTLY. HOWEVER, THE PATIENT WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE HOSPITAL NAMES, SURGEON NAMES, AND PROCEDURE DATES ARE UNKNOWN. THERE IS ALSO NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT A DA VINCI SURGICAL PROCEDURE AND EXPERIENCED OPERATIVE COMPLICATIONS. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "34218647", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 07/28/2015, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE PATIENT REGARDING THE REPORTED EVENT. THE PATIENT UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2013 AT A SPECIFIED HOSPITAL. ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT ON 08/25/2015 AND OBTAINED CONFIRMATION THAT THE PATIENT UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2013. THE RISK MANAGER REVIEWED THE DA VINCI OPERATIVE REPORT AND DID NOT FIND ANY INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE RISK MANAGER WAS UNWILLING TO PROVIDE ANY OTHER INFORMATION REGARDING THE PATIENT. ON (B)(6) 2013, THE PATIENT UNDERWENT COLON SURGERY BY ANOTHER SURGEON AT AN UNSPECIFIED SITE. A REVIEW OF THE SURGEON'S DA VINCI SURGERY HISTORY REVEALED THAT THE SURGEON DID NOT PERFORM ANY DA VINCI SURGICAL PROCEDURES ON (B)(6) 2013. ACCORDING TO THE SURGEON'S DA VINCI SURGERY HISTORY, HER FIRST DA VINCI SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT INDICATED THAT SHE ALSO UNDERWENT A COLONOSCOPY PROCEDURE PERFORMED BY A GI SPECIALIST. BASED ON THE PHYSICIAN'S NAME PROVIDED BY THE PATIENT, THERE IS NO RECORD THAT THE PHYSICIAN HAS EVER PERFORMED A DA VINCI SURGICAL PROCEDURE. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT A DA VINCI SURGICAL PROCEDURE IN ADDITION TO SUBSEQUENT NON-DA VINCI RELATED SURGICAL PROCEDURES AND CLAIMED THAT SHE EXPERIENCED VARIOUS OPERATIVE COMPLICATIONS. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS ARE STILL UNKNOWN." }, { "mdr_text_key": "15967693", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A MAUDE EVENT REPORT MW5040668 WITH THE FOLLOWING EVENT DESCRIPTION: INJURIES TO MY BLADDER, COLON, BURS, PELVIS, AND MY LUNGS COLLAPSE, LIVER AND SPLEEN. SURGERY WAS PERFORMED AT (B)(6) WITH THE ASSIST OF THE DA VINCI ROBOT. I RECEIVED LAPAROSCOPIC LYSIS OF ADHESIONS, ROBOTIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY SURGERY. PERFORMED BY SURGEON (B)(6) ON (B)(6) 2013. TRANSFERRED MY CARE TO (B)(6) STARTED SEEING A DR. (B)(6) GI SPECIALIST WHO RECOMMEND I SEE A COLORECTAL SURGEON BY THE NAME OF (B)(6). SHE PERFORMED MULTIPLE SURGERIES BUT FAIL TO NOTE THE INFORMATION IN THE OPERATIVE REPORT. DR. (B)(6) SCHEDULED ME TO HAVE A COLONOSCOPY PERFORMED ON (B)(6) 2014. MY COLONOSCOPY WAS INCOMPLETE AND I NEVER WAS INFORMED WHY AND SURGERY WAS PERFORMED BUT NEVER MENTION IN THE OPERATIVE REPORT. I REPORTED THIS INFORMATION TO PATIENTS RELATION AND THE MATTER WAS INVESTIGATED. I RECEIVED A LETTER FROM PATIENT'S RELATION STATING DR. (B)(6) WILL NO LONGER BE PRACTICING WITH (B)(6). MY MEDICAL RECORDS WAS BOTCHED TO COVER UP MY INJURIES FROM (B)(6). HAVE HIRED BOTH OF THE SURGEONS. I HAVE PROOF OF EVERYTHING STATED. I ALSO DEVELOPED C-DIFF AND FEVER AFTER SURGERY FOR THREE CONSECUTIVE DAYS. NO FEEL IN THE LEFT SIDE OF MY ARM, HORRIBLE PAIN. COULD NOT WALK FOR THE FIRST TWO DAYS. LOST MY JOB BEHIND ALL OF THIS.*" } ], "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": "08/27/2015" } ] }