{ "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": "2955842-2013-03197", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130826", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110921", "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": "20130826", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "416698", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130826", "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": "IS 3000 A60.P8", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20130826", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "80 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Inflammation", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306715", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "3591644", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI SACROCOLPOPEXY PROCEDURE ON (B)(6) 2011 FOR VAGINAL PROLAPSE. THE OPERATIVE NOTES INDICATE THAT THE PATIENT'S UTERUS AND RIGHT ADNEXA WERE ABSENT AND THE LEFT ADNEXA AND LEFT SIGMOID COLON WERE SCARRED TOGETHER. THE USE OF MONOPOLAR SCISSORS AND PK INSTRUMENTS WERE MENTIONED IN THE PROCEDURE NOTES, BUT THERE WAS NO REPORT OF A DA VINCI SI SYSTEM OR INSTRUMENT MALFUNCTION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ACCORDING TO THE MEDICAL RECORD, THE PATIENT DID NOT HAVE ANY COMPLICATIONS WITH THE DA VINCI SI SURGICAL PROCEDURE. THE PATIENT HAD SOME LOW BACK PAIN THAT WAS FELT TO BE RELATED TO POSITIONING THAT KEPT HER FROM AMBULATING QUICKLY. SHE WAS DISCHARGED TO RETURN HOME ON HOSPITAL DAY NUMBER THREE. IN (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH A PELVIC ABSCESS, DIVERTICULITIS OF THE COLON WITH PERFORATION, AND HAD A SIGMOID COLECTOMY. THE PATIENT NOTED AS BEING HOSPITALIZED SEVERAL TIMES THROUGHOUT (B)(6) 2011 THROUGH (B)(6) 2012, FOR BACK AND LEG ISSUES (OSTEOMYELITIS OF LUMBAR SPINE, DISKITIS, LUMBAR SPONDYLOSIS, AND RADICULOPATHY). THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED." }, { "mdr_text_key": "11065530", "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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL SACROCOLPOPEXY 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": "" } ] }