{ "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": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SUNNYVALE", "manufacturer_contact_address_1": "950 KIFER RD.", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2013-03132", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20090810", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94086", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "REED", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94086", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20130823", "manufacturer_contact_f_name": "TABITHA", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410349", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": [ "Defective Device", "Insufficient Device Problem Information" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/05/2025", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250825", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20130823", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES.", " DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIES.", " NA.", " NA.", " NA.", " DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE" ], "sequence_number_outcome": [ "Life Threatening", " H", " R" ], "patient_age": "54 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Bowel Burn", "Dyspnea", "Dyspnea", "Pneumonia", "Pneumonia", "Sepsis", "Sepsis", "Injury", "Injury", "Obstruction/Occlusion", "Obstruction/Occlusion", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available" ] } ], "distributor_city": "", "date_report": "20250305", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SUNNYVALE", "mdr_report_key": "3305471", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "94086", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "3588428", "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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGOOOPHORECTOMY AND LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2009. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT SUSTAINED A THERMAL INJURY TO THE SMALL BOWEL CAUSING A LARGE ABSCESS TO FORM AND CAUSING A LARGE BOWEL OBSTRUCTION. ALSO STATED THAT THE JEJUNAL ENTEROTOMY WAS CONSISTENT WITH A LOW VOLTAGE INJURY TO THE SMALL BOWEL THAT OCCURRED FROM AN INSULATION DEFECT IN THE SHAFT OF THE MONOPOLAR SCISSORS USED DURING HER ROBOTIC HYSTERECTOMY. AS A RESULT OF THE BOWEL INJURY, THE PATIENT DEVELOPED A LARGE RIGHT PERIO-COLIC ABSCESS AND REQUIRED AN EXTENSIVE OPERATION WITH REMOVAL OF THE RIGHT COLON. AS A DIRECT CONSEQUENCE OF THE BOWEL INJURY, SHE HAD SEPSIS AND LATER DEVELOPED A HOSPITAL-ACQUIRED PNEUMONIA REQUIRING READMISSION AND EXTENSIVE TREATMENT. THE SURGERY PERFORMED ON (B)(6) 2009, FOUND THAT THE PATIENT HAD A NORMAL ANATOMY WITH SOME ADHESIONS FROM THE PREVIOUS CESAREAN BUT THERE WAS NO OTHER EVIDENCE OF EXTRA-UTERINE DISEASE. THE PATIENT REQUIRED EXPLORATORY LAPAROTOMY FOR POSTOP BLEEDING. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT WAS EVALUATED AT ANOTHER HOSPITAL FOR WHAT WAS REPORTED AS INCREASED ABDOMINAL DISTENSION AND DISCOMFORT. SHE UNDERWENT AN EXPLORATORY LAPAROTOMY WHICH REVEALED A SMALL BOWEL PERFORATION INVOLVING THE MID JEJUNUM AND A LARGE PERI-COLONIC ABSCESS WHICH REQUIRED A REPAIR OF THE MID JEJUNAL ENTEROTOMY EXTENDED RIGHT HEMI-COLECTOMY, APPENDECTOMY, AND CHOLECYSTECTOMY. THE PATIENT WAS HOSPITALIZED UNTIL (B)(6) 2009, ACCORDING TO THE LEGAL COMPLAINT. ON (B)(6) 2009, THE PATIENT WAS EVALUATED FOR A COMPLAINT OF SHORTNESS OF BREATH. SHE WAS DIAGNOSED WITH MULTIFOCAL HOSPITAL-ACQUIRED PNEUMONIA. THE PATIENT RECEIVED WOUND-VAC THERAPY FOR HER INCISION AND WAS TREATED WITH TRIPLE INTRAVENOUS ANTIBIOTIC THERAPY. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2009." }, { "mdr_text_key": "11012327", "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. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BOWEL INJURY DURING A DA VINCI HYSTERECTOMY PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "950 KIFER RD.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94086", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/10/2025" } ] }