{ "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": "2955842-2013-03550", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130913", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110601", "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": "20130913", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "462799", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130913", "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": "IS200", "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": "20250812", "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": "20130913", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "28 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3348048", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "3863326", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE PATIENT HAD A LONG HISTORY OF DYSFUNCTIONAL BLEEDING, MENORRHAGIA, AND PELVIC PAIN. THE PATIENT HAS HAD PREVIOUSLY 9 LAPAROSCOPIES, ONE OF WHICH RESULTED IN A RIGHT SALPINGO OOPHORECTOMY. IN ADDITION, SHE HAS HAD 2 PRIOR CESAREAN SECTIONS. ACCORDING TO THE OPERATIVE REPORTS, THERE WAS A LITTLE BIT OF OOZING COMING FROM THE OMENTUM, WHEN PUTTING IN THE VERESS NEEDLE AND TROCAR. THE SURGEON NOTED SOME BLOOD AROUND THE OMENTUM; HOWEVER, NO OBVIOUS BOWEL OR OTHER INJURY WAS IMMEDIATELY APPARENT. THE SURGEON DECIDED TO CONTINUE WITH THE HYSTERECTOMY PROCEDURE UNTIL MORE OOZING WAS NOTED TO BE COMING FROM THE UPPER ABDOMINAL AREA. THERE WAS AN AREA OF HEMATOMA OVER THE SACRAL REGION OBSERVED FOR SEVERAL MINUTES. SINCE IT WAS NOT EXPANDING, A DECISION WAS MADE TO CONTINUE TO RECHECK IT. THE SURGEON COMPLETED THE HYSTERECTOMY PROCEDURE AND THEN WENT BACK TO RECHECK THE AREA OF HEMATOMA. THE SURGEON DECIDED TO CONSULT WITH A VASCULAR SURGEON. THE VASCULAR SURGEON INSPECTED THE AREA LAPAROSCOPICALLY AND DECIDED THAT THE PATIENT NEEDED TO HAVE FURTHER EXPLORATION VIA AN OPEN ABDOMINAL APPROACH. IT WAS NOTED IN THE OPERATIVE REPORTS THAT THERE WAS SOME QUESTION OF PERHAPS AN INJURY WITH THE VERESS NEEDLE UPON INSERTION AND INSUFFLATION OF THE ABDOMEN. THE VASCULAR SURGEON CONFIRMED THERE WAS A SMALL RETROPERITONEAL HEMATOMA AND THERE WAS A HEMORRHAGE FROM THE INTERNAL ILIAC ARTERY, WHICH WAS REPAIRED DURING THE VASCULAR SURGEON'S PORTION OF THE SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. HER DISCHARGE SUMMARY INDICATED THAT THE PATIENT HAD AN INTEROPERATIVE ESTIMATED BLOOD LOSS OF 1100 CC, OF WHICH 50 CC WAS PRIOR TO THE OPEN AND REPAIR OF THE ILIAC ARTERY INJURY . THE OPERATIVE REPORTS DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT'S CURRENT CONDITION WAS NOT REPORTED AND NO FURTHER MEDICAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11175933", "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 INTRA-OPERATIVE INJURY EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. 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 INTRA-OPERATIVE INJURY EXPERIENCED BY THE PATIENT. 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 AN INJURY DURING A DA VINCI S HYSTERECTOMY 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": "" } ] }