{ "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": "2955842-2013-03161", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20121203", "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": "409827", "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": "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": [ "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": "20250814", "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 S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "41 YR", "patient_sex": "", "patient_weight": "80", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Anemia", "Pneumonia", "Sepsis" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305656", "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": "3835464", "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 RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S LYSIS OF ADHESIONS, BILATERAL SALPINGO-OOPHORECTOMY, APPENDECTOMY, CYSTOSCOPY AND CERVICAL STRUMECTOMY WHICH WERE PERFORMED ON (B)(6) 2012. PER THE OPERATIVE REPORTS, DENSE ABDOMINAL PELVIC ADHESIONS, CONSISTENT WITH THE PATIENT'S HISTORY OF PRIOR SURGERIES, LAPAROSCOPIC BANDING AND ENDOMETRIOSIS. THERE WAS A DENSE ADHESION SURROUNDING THE LAP BAND FROM THE OMENTUM AND THE SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL REQUIRING APPROXIMATELY AN HOUR AND A HALF OF ADHESIOLYSIS TO NORMALIZE THE ANATOMY. THE SAME WAS FOUND IN THE PELVIS WITH THE OVARIES. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE OP REPORT DID NOT ALLEGE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WERE NO ANOMALIES NOTED. PER THE INFORMATION IN THE OP REPORT, THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURES WELL. THE SURGEON'S POST-OPERATIVE DIAGNOSIS WERE PELVIC ADHESIVE DISEASE, ABDOMINAL ADHESIVE DISEASE, AND ENDOMETRIOSIS. ON (B)(6) 2012, A CT ABDOMEN AND PELVIS REVEALED EXTENSIVE PNEUMOPERITONEUM AND A LARGE PELVIC COLLECTION SUSPICIOUS FOR AN ABSCESS. ON (B)(6) 2013, SHE WAS TAKEN BACK TO THE OPERATING ROOM AND UNDERWENT REPAIR OF A PERFORATED ILEUM AND LYSIS OF ADHESIONS. THE PATIENT HAD A COMPLICATED POST-OPERATIVE COURSE, INCLUDING ICU STAY FOR ONE MONTH, REMAINING INTUBATED (FOLLOWED BY TRACHEOTOMY PLACEMENT), ANEMIA, SEPSIS, AND PNEUMONIA. SHE WAS DISCHARGED STABLE. PER THE MEDICAL RECORD FOR THE POST-OPERATIVE FOLLOW UP VISIT ON (B)(6) 2013 THE PATIENT REPORTED THAT SHE HAD IMPROVED AND WAS DOING BETTER." }, { "mdr_text_key": "11019770", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ON (B)(4) 2013 INTUITIVE SURGICAL CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE HOSPITAL TO GATHER ADDITIONAL INFORMATION ABOUT THIS CASE, BUT THEY WERE UNABLE TO PROVIDE ANY INFORMATION REGARDING THIS CASE. RISK MANAGEMENT INDICATED THAT SHE WOULD HAVE TO FOLLOW UP WITH THE SURGEON AND THEY WOULD CONTACT INTUITIVE SURGICAL IF ANY INFORMATION BECOMES AVAILABLE. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI S 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": "" } ] }