{ "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": "2955842-2013-03165", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111208", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH PROFESSIONAL", "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": "409801", "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": "", "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": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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 SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Fever", "Perforation", "Scarring" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305995", "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": "3836783", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL COMPLAINT EFFORT, ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS, OF A PATIENT WHO DEVELOPED POST- SURGICAL COMPLICATIONS AFTER HAVING A DA VINCI SI BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011 FOR A LEFT OVARIAN COMPLEX CYST. THE PATIENT HISTORY SHOWED MULTIPLE ABDOMINAL SURGERIES IN THE PAST AND THE PATIENT WAS EXPECTED TO HAVE A LARGE AMOUNT OF ADHESIONS IN THE SMALL AND LARGE INTESTINE. THE ADHESIONS WERE REMOVED BEFORE BEGINNING THE BSO PROCEDURE. THESE ADHESIONS WERE REMOVED WITH SCISSORS. DURING THE DA VINCI SI PROCEDURE BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE IT WAS NOTED BT THE SURGEON THAT EXTENSIVE OMENTAL AND COLON ADHESIONS WERE REMOVED WITH SCISSORS AND THAT A VERY SMALL RENT IN THE SMALL INTESTINE WAS LIKELY DUE TO A THERMAL BURN WHICH WAS THEN REPAIRED DURING THIS PROCEDURE AND EXCELLENT HEMOSTASIS WAS NOTED. POST- SURGERY THE PATIENT HAD SOME ABDOMINAL PAIN AND SHE WAS DISCHARGED ON (B)(6) 2011. THE FOLLOWING DAY THE PATIENT COMPLAINED ABOUT ABDOMINAL PAIN AND WAS READMITTED ON (B)(6) 2011 WITH ABDOMINAL PAIN AND FEVER. SHE WAS TREATED WITH PAIN MEDICATIONS AND KEFLEX FOR A PROBABLE POSTOPERATIVE ILEUS AND DISCHARGED ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH PERSISTENT PAIN. THE PATIENT WAS EVALUATED AND A CT SCAN OF THE ABDOMEN REVEALED A DEFECT IN THE RIGHT LOWER QUADRANT OF THE ABDOMEN WITH LEAKING AIR AND ORAL CONTRAST, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A DISTAL ILEAL PERFORATION REPAIR WITH DRAINAGE OF ANTERIOR ABDOMINAL WALL ABSCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. IT WAS NOTED THAT THE PATIENT'S BOWEL PERFORATION WAS PRESUMED TO BE SECONDARY TO THE PATIENT'S SURGERY 6 DAYS PRIOR. PATIENT WAS TREATED FOR SEPSIS AND ACUTE RENAL FAILURE POSTOPERATIVELY AND WAS DISCHARGED ON (B)(6) 2011. IN (B)(6) 2012, THE PATIENT HAD PLASTIC SURGERY TO EXCISE THE ABDOMINAL SCAR FROM THE ABOVE MENTIONED SURGERY, ALONG WITH LYSIS OF ADHESIONS AND REPAIR OF AN INCISIONAL HERNIA. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO FURTHER CLINICAL INFORMATION HAS BEEN PROVIDED ABOUT THE PATIENT'S CURRENT HEALTH STATUS." }, { "mdr_text_key": "11074571", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE 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. THE DOCUMENTATION PROVIDED DOES NOT HAVE 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. INTUITIVE SURGICAL INC.(ISI) HAS REVIEWED THE SYSTEM LOGS FOR THIS SITE WITH A PROCEDURE DATE OF (B)(6) 2011 AND CONFIRMED THAT THERE WERE NO SYSTEM ERRORS GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL BILATERAL SALPINGO-OOPHORECTOMY 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": "" } ] }