{ "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": "2955842-2013-04780", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110809", "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": "20131031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "559220", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "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": [ "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": "20250805", "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": "20131031", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "40 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Adhesion(s)", "Cellulitis", "Hemorrhage/Blood Loss/Bleeding", "Thrombus" ] } ], "distributor_city": "", "date_report": "20131001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440257", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131001", "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": "3854463", "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 HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, AND EXTENSIVE LYSIS OF ADHESIONS FOR CHRONIC PELVIC PAIN AND ENDOMETRIOSIS ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND LIMITED SUBSEQUENT MEDICAL RECORDS. ADDITIONAL INFORMATION PROVIDED INCLUDES MULTIPLE CT SCANS OF THE ABDOMEN AND PELVIS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PELVIC ANATOMY WAS ABNORMAL HOWEVER AND THERE WERE MULTIPLE ADHESIONS AND SIGNS OF ENDOMETRIOSIS. THIS INVOLVED THE OVARIES AND COMPLETELY OBLITERATED THE CUL-DE-SAC AND MADE VISUALIZATION OF THE POSITION OF THE URETERS QUITE DIFFICULT THE PATIENT PRESENTED 9 DAYS AFTER SURGERY WITH SYMPTOMS OF BLEEDING AND WAS DIAGNOSED WITH A CUFF CELLULITIS AND CT SCANS SHOWED POSSIBLE ABSCESSES. SHE RETURNED TO THE OR FOR A DIAGNOSTIC LAPAROSCOPY AND RE-SUTURING OF THE VAGINAL CUFF. HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, AND EXTENSIVE LYSIS OF ADHESIONS PERFORMED ON (B)(6) 2011. POSTOP COURSE UNCOMPLICATED, DISCHARGED WITH PAIN MEDICATION ON (B)(6) 2011. PRESENTED ON (B)(6) 2011 WITH VAGINAL BLEEDING, CLOTS, AND ODOR. CURRENT USE OF ANTIBIOTIC. ADMITTED FOR CUFF DISRUPTION AND INFECTION. POSSIBLE VAGINAL HEMATOMA ON (B)(6) 2011 DIAGNOSTIC LAPAROSCOPY AND REPAIR OF VAGINAL CUFF PERFORMED. OPERATIVE FINDINGS INCLUDED CLOTS AND INDURATION AT AREA OF VAGINAL CUFF WITH COMPLETE BREAK DOWN OF THE VAGINAL CUFF AND DIFFUSE BLEEDING ACROSS THIS. MILD ADHESIONS TO VAGINAL CUFF ALSO NOTED. ON (B)(6) 2011, CT OF ABDOMEN AND PELVIS PERFORMED FOR A HISTORY OF VAGINAL BLEEDING. STUDY REVEALED MULTIPLE INTRA-ABDOMINAL FLUID COLLECTIONS OF WHICH 2 WERE CONSISTENT WITH AN ABSCESS, 1 WITHIN THE LIVER POSTERIORLY AND 1 AT THE TIP OF THE LIVER. ON (B)(6) 2011, CT-GUIDED DRAINAGE OF BOTH RIGHT ABDOMINAL ABSCESSES PERFORMED. ON (B)(6) 2011, FOLLOW-UP CT REVEALED RESOLUTION OF BOTH FLUID COLLECTIONS. THERE CONTINUED TO BE A FLUID COLLECTION IN THE RIGHT HEAD OF THE PELVIS, ALTHOUGH THIS HAD DECREASED IN SIZE. SURGICAL SITE WITH AIR WITHIN THE REGION OF THE VAGINAL CUFF IS STILL DEMONSTRATED. ON (B)(6) /2011, SEEN BY A PHYSICIAN FOR GYN FOLLOW-UP. NOTED TO BE RECOVERING WELL. ADVISED SHE COULD RETURN TO WORK PART-TIME, BUT WAS TO CONTINUE PELVIC REST AND LIFTING RESTRICTIONS FOR AT LEAST 2 MORE WEEKS. TO RETURN AS NEEDED. NO FURTHER RECORDS PROVIDED." }, { "mdr_text_key": "11098399", "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 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 VAGINAL CUFF BLEEDING AND DEVELOPED ABDOMINAL ABSCESSES AFTER UNDERGOING A DA VINCI SI HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, AND EXTENSIVE LYSIS OF ADHESIONS FOR CHRONIC PELVIC PAIN AND ENDOMETRIOSIS." } ], "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": "" } ] }