{ "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": "2955842-2012-00446", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20120914", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20001031", "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": "20120917", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120914", "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": "N", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "", "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": "20120914", "sequence_number_treatment": [ "DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Inflammation", "Laceration(s)", "Pain", "Scarring", "Tissue Damage", "Disability" ] } ], "distributor_city": "", "date_report": "20120709", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2746273", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120709", "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": "21208102", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL IS CURRENTLY INVESTIGATING THE REPORTED EVENT. A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION HAS BEEN PROVIDED." }, { "mdr_text_key": "20981080", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED A PATIENT STORY POSTED ON THE INTERNET CONCERNING THEIR DA VINCI HYSTERECTOMY SURGICAL PROCEDURE: THE PATIENT INDICATED THAT ON (B)(6) 2000 SHE UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE AT (B)(6) HOSPITAL (LOCATION UNKNOWN) AND DURING THE SURGICAL PROCEDURE HER BLADDER WAS NICKED. THE PATIENT INDICATED THAT PRIOR TO THE SURGICAL PROCEDURE; SHE WAS ADVISED TO UNDERGO A HYSTERECTOMY WITH CYSTOCELE AND RECTOCELE REPAIR. THE PATIENT INDICATED THAT HER DOCTOR ADVISED HER THAT HER BLADDER DURING THE SURGICAL PROCEDURE WAS NOT ADDRESSED BECAUSE IT HAD DESCENDED TO A LEVEL 3, HER CERVIX WAS NOT REMOVED AND THE RECTOCELE WAS REPAIRED. THE PATIENT INDICATED THAT 2 DAYS POST OP SHE WAS RELEASED FROM THE HOSPITAL AND THAT SHE DID NOT RECOVER FROM THE SURGICAL PROCEDURE. THE PATIENT INDICATED FOR 7 DAYS AFTER THE DA VINCI SURGICAL PROCEDURE, HER BLADDER WOULD HARDEN AND SHE FELT AS THOUGH SHE WAS EXPERIENCING END STAGE LABOR AND HAD TO SEEK A SPECIALIST FOR HER BLADDER. THE PATIENT INDICATED THAT EXAMINATION BY THE SPECIALIST FOUND THAT HER BLADDER EXHIBITED EXTENSIVE SCARRING, MUSCLE DAMAGE AND THERE WAS NO EVIDENCE OF RECTOCELE REPAIR. THE PATIENT INDICATED THAT SHE UNDERWENT A PAP SMEAR, PERFORMED BY A PHYSICIAN'S ASSISTANT (PA) AND THE PA COULD NOT FIND THE PATIENT'S CERVIX AND THAT THE PATIENT EXHIBITED SERIOUS INFLAMMATION. THE PATIENT ALSO INDICATED THAT SHE EXPERIENCED DISCOMFORT DURING THE PAP EXAMINATION. THE PATIENT INDICATED THAT SHE REQUIRES ANOTHER SURGERY AND IS CURRENTLY UNDER FULL DISABILITY. LATE SUBMISSION OF THIS MEDWATCH REPORT IS DUE TO A DATA ENTRY OVERSIGHT BY THE RESPONSIBLE CUSTOMER SERVICE REPRESENTATIVE." } ], "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": "" } ] }