{ "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": "2955842-2013-04925", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20090310", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562153", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "20250824", "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": "20131101", "sequence_number_treatment": [ "DA VINCI S SURG SYS INST., ACCESSORIES, & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "60 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444172", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "3781897", "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 WHO UNDERWENT A DA VINCI SI VAGINAL VAULT REPAIR ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. MULTIPLE PRE-OP AND POST-OP REPORTS ARE INCLUDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION - NAMELY A TEAR OF THE INFERIOR VENA CAVA. UPON ENTERING THE ABDOMEN EXTENSIVE ADHESIONS WERE NOTED AND ONE HOUR WAS SPENT LYSING THEM PRIOR TO THE ROBOTIC INSTRUMENTS BEING PLACED. ALL WERE RELEASED EXCEPT FOR ONE, WHICH WAS HERNIATED THROUGH A PREVIOUS INCISION SITE. FURTHER ENTEROLYSIS WAS PERFORMED AFTER THE ROBOT WAS DOCKED. THE LOOP OF SMALL BOWEL THAT WAS ATTACHED THROUGH THE ANTERIOR ABDOMINAL WALL HERNIATION SITE WAS RELEASED USING THE ROBOT. THE SMALL BOWEL WHICH WAS INVOLVED IN THIS PART WAS EXAMINED AND THE SEROSA NOTED TO BE SOMEWHAT DENUDED. THIS AREA IS OVERSEWN WITH SUTURE. SHORTLY AFTER THE SACRAL PROMONTORY WAS IDENTIFIED AND EXPOSED BLEEDING WAS NOTED FROM THE INFERIOR PORTION OF THE VENA CAVA. VASCULAR SURGEONS WERE BROUGHT IN AND CLIPS WERE PLACED IN THE TEAR. FIBRIN GLUE AND SURGICEL WERE APPLIED OVER THE REPAIR. HEMOSTASIS WAS CONFIRMED. THE VAGINAL CUFF IS THEN DISSECTED. A CYSTOTOMY OCCURRED AND WAS OVERSEWN AND WATER TIGHTNESS IS CHECKED WITH INDIGO CARMINE. THE ROBOTIC PORTION COMPLETE, AN ANTERIOR REPAIR OF THE VAGINA WAS INITIATED. AFTER THIS WAS COMPLETED UNEVENTFULLY USING MESH, A CYSTOSCOPY REVEALED GOOD URETERAL FUNCTION AND A SEALED BLADDER. A SMALL VASCULAR CLIP WAS NOTED IN THE BLADDER, AND IT WAS REMOVED THROUGH THE CYSTOSCOPE OPERATING PORT. THE PATIENT TOLERATED THE TVT-O PROCEDURE WELL AND WAS TRANSFERRED TO THE PACU IN STABLE CONDITION. A POSTOPERATIVE VISIT OCCURRED ON (B)(6) 2009 DURING WHICH PAIN AND A LUMP NEAR THE INCISION SITE WERE NOTED. A CT SCAN ON (B)(6) 2009, SHOWED AN ABDOMINAL HEMATOMA OR ABSCESS. THE PATIENT CALLED THE PHYSICIAN ON (B)(6) 2009, REQUESTING TRANSFER OF CARE, AS SHE DID NOT RECEIVE PROPER POST-OPERATIVE CARE. NARRATIVE NOTES INFER THAT THE PATIENT - PHYSICIAN RELATIONSHIP HAD SIGNIFICANTLY SOURED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE NARRATIVE OF THE PHONE CONVERSATION OF (B)(6) 2009." }, { "mdr_text_key": "11252661", "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 FOR THE INTRA-OPERATIVE AND POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED INTRA-OPERATIVE AND POST-OPERATIVE COMPLICATIONS FROM 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": "" } ] }