{ "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": "2955842-2013-03150", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20101217", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410070", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI SI 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": "IS3000 A6.0P8", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTRUMENTS, ACCESS & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Emotional Changes", "Hypoxia", "Incontinence", "Pain", "Renal Failure", "Sepsis", "Septic Shock", "Thyroid Problems", "Brain Injury", "Anxiety", "Injury", "Deformity/ Disfigurement", "Disability", "Cognitive Changes", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305585", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131008", "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": "21674675", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE. THE LEGAL COMPLAINT ALLEGES THAT DURING THE SURGICAL PROCEDURE, THE PATIENT SUSTAINED BOWEL PERFORATION. AS A RESULT OF HER BOWEL INJURY THE PATIENT DEVELOPED SEPSIS, EXPERIENCED SEPTIC SHOCK, RENAL FAILURE, HYPOXIC BRAIN INJURY, THYROID INJURY, GALLBLADDER DAMAGE, COGNITIVE DEFICITS, AND URINARY AND BOWEL INCONTINENCE. PER THE INFORMATION IN THE LEGAL COMPLAINT, THE PATIENT HAS SUFFERED SEVERE AND PERMANENT INJURIES INCLUDING SEVERE INTERNAL INJURIES, PAIN, DISABILITY, PHYSICAL IMPAIRMENT, MENTAL IMPAIRMENT, DISFIGUREMENT, MENTAL ANGUISH, INCONVENIENCE AND LOSS OF CAPACITY FOR THE ENJOYMENT OF LIFE, ALL OF WHICH ARE CONTINUING AND ARE PERMANENT IN NATURE. NO OTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "24923398", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A COPY OF THE PATIENT'S OPERATIVE (OP) REPORT. ACCORDING TO THE INFORMATION INDICATED IN THE OP REPORT, THE PATIENT UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY FOR ABNORMAL UTERINE BLEEDING AND PELVIC PAIN ON (B)(6) 2010. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. MINIMAL SIGMOID COLONIC FILMY ADHESIONS WERE FOUND TO THE POSTERIOR UTERUS. NO OTHER SIGNIFICANT FINDINGS NOTED. NO OTHER INFORMATION REGARDING THE PATIENT WAS PROVIDED." }, { "mdr_text_key": "21910913", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THE DIRECTOR OF RISK MANAGEMENT INDICATED THAT DUE TO LEGAL CONSTRAINTS SHE WAS UNABLE TO PROVIDE INFORMATION REGARDING THE PATIENT OR THE REPORTED EVENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BOWEL PERFORATION DURING A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." } ], "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": "11/06/2013" } ] }