{ "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": "2026-09-22", "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": "2955842-2013-04718", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131030", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110413", "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": "20131030", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "557334", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131030", "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, 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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20131030", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20130930", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3438352", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130930", "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": "3897672", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI LAPAROSCOPIC SIGMOID COLECTOMY WITH RECTOPEXY FOR CHRONIC RECTAL PROLAPSE ON (B)(6) 2011. THE PATIENT HAD A CONDITION OF CHRONIC SMALL BOWEL OBSTRUCTION PRIOR TO HER SURGERY FOR RECTAL PROLAPSE. INTUITIVE SURGICAL, INC. (ISI) WAS PROVIDED WITH THE OPERATIVE REPORT FROM (B)(6) 2011. ADDITIONAL INFORMATION PROVIDED INCLUDES CLINIC NOTES (B)(6) 2011, ER VISIT (B)(6) 2011, HOSPITAL ADMISSION (B)(6) 2011, CT SCAN (B)(6) 2011, ABDOMINAL X-RAY (B)(6) 2011, CT SCAN (B)(6) 2011, CT SCAN (B)(6) 2011, CT SCAN (B)(6) 2011, X-RAY (B)(6) 2011, ER VISIT (B)(6) 2011, CT (B)(6) 2011, X-RAY (B)(6) 2011, CLINIC NOTE (B)(6) 2011, AND COLONOSCOPY (B)(6) 2010. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. ACCORDING TO THE OPERATIVE REPORT, THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AFTER THE PROLAPSE SURGERY, HER RECOVERY WAS PROLONGED BY THE DEVELOPMENT OF A POSSIBLE ABSCESS IN THE PRE-SACRAL AREA FOR WHICH SHE WAS ADMITTED TO A HOSPITAL. SHE WAS TREATED WITH ANTIBIOTICS AND DRAINAGE BEGINNING (B)(6) 2011. SHE WAS READMITTED ON (B)(6) 2011 WITH SYMPTOMS RELATED TO SMALL BOWEL OBSTRUCTION BUT REQUIRED NO INTERVENTION. FOLLOW UP STUDIES HAVE SHOWN GRADUAL DECREASE IN SIZE OF THE ABSCESS, BUT WITH CONTINUED SYMPTOMS OF HER SMALL BOWEL OBSTRUCTIVE PROBLEM AND CHRONIC CONSTIPATION. HER RECTAL PROLAPSE HAS NOT RETURNED. SHE IS EATING AND PASSING STOOL AND FLATUS WITHOUT PROBLEM. NO OTHER DATA HAS BEEN MADE AVAILABLE." }, { "mdr_text_key": "11396291", "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. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL 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": "" } ] }