{ "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": "2955842-2013-03154", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110914", "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": "409727", "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": "20250818", "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, ESU, INSTRUMENTS & ACCESSORIE" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "38 YR", "patient_sex": "", "patient_weight": "66", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305610", "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": "3711416", "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 THAT UNDERWENT A DA VINCI SI RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011. PER THE RECORDS RECEIVED THE SURGERY WAS UNREMARKABLE. IMMEDIATELY FOLLOWING THE INITIAL SURGERY, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR HYPOTENSION AND WAS NOTED TO HAVE A LARGE AMOUNT OF BLOOD IN THE UPPER ABDOMEN AND PELVIS. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY WHICH WAS CONVERTED TO AN EXPLORATORY LAPAROTOMY WITH NO CLEAR FINDING IN REGARD TO THE ABSOLUTE SOURCE OF THE BLEEDING. THE PATIENT WENT TO THE RECOVERY ROOM IN A STABLE CONDITION. THE PATIENT RECOVERED WELL AND WAS DISCHARGED ON DAY 5 ((B)(6) 2011) THE PATIENT WAS THEN SEEN AND READMITTED ON (B)(6) 2011, WITH A PERI-HEPATIC ABSCESS. THE PATIENT REQUIRED ANTIBIOTICS AND A FOUR DAY HOSPITALIZATION, AND UNDERWENT A CT GUIDED INTERVENTIONAL RADIOLOGY DRAINAGE OF THE ABSCESS. PER THE INITIAL OPERATIVE REPORT FOR THE (B)(6) 2011 PROCEDURE, THE PATIENT TOLERATED THE OOPHORECTOMY PROCEDURE WELL. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM REPORTEDLY IN STABLE CONDITION. PER THE DISCHARGE SUMMARY COMPLETED AT THE HOSPITAL, THE PATIENT UNDERWENT AN UNEVENTFUL ROBOTIC-ASSISTED RIGHT SALPINGO OOPHORECTOMY. HOWEVER, IN THE POSTOP PERIOD, SHE WAS NOTED TO HAVE HYPOTENSION AND SEVERE ABDOMINAL PAIN. THERE WAS CONCERN FOR AN INTRA-ABDOMINAL BLEED. A DECISION WAS MADE TO PROCEED WITH A CT SCAN TO EVALUATE THE ABDOMEN AND PELVIS. CT SCAN OF THE ABDOMEN REVEALED INTRA-ABDOMINAL BLOOD. PATIENT WAS TAKEN BACK TO THE OPERATING ROOM, WHERE A DIAGNOSTIC LAPAROSCOPY WAS DONE INITIALLY; HOWEVER, THE BLEEDER WAS UNABLE TO BE ISOLATED, SO THE PATIENT WAS CONVERTED TO AN INTRA-ABDOMINAL PROCEDURE, EXPLORATORY LAPAROTOMY. THE SUSPECTED AREA OF BLEEDING WAS LIGATED; HOWEVER, NO DEFINITE AREA WAS FOUND TO BE BLEEDING. THE PATIENT POST-OPERATIVE PERIOD WAS UNREMARKABLE. SHE DID RECEIVE A TRANSFUSION OF PACKED RED BLOOD CELLS, WHICH SHE TOLERATED WELL. HER DIET WAS ADVANCED SLOWLY DUE TO MULTIPLE PROCEDURES AND INTRA-ABDOMINAL BLOOD. HOWEVER, HER DIET WAS PROGRESSED AND SHE AMBULATED AND SHE HAD BOWEL MOVEMENTS, WAS PASSING FLATUS AND HER PAIN WAS WELL CONTROLLED. SHE WAS DISCHARGED HOME ON POST-OPERATIVE DAY NUMBER 5, STAPLES WERE REMOVED." }, { "mdr_text_key": "11064376", "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 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. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2011 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT." } ], "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": "" } ] }