{ "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": "2955842-2013-04943", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121108", "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": "562202", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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 A6.0P6", "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": "20131101", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "27 YR", "patient_sex": "", "patient_weight": "147", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Abdominal Pain", "Purulent Discharge", "Incontinence", "Nausea", "Pain", "Swollen Lymph Nodes", "Hot Flashes/Flushes", "Anxiety", "Discomfort", "Sweating", "Post Operative Wound Infection", "Dysuria" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444226", "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": "3900657", "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 TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC WASHINGS AND LYSIS OF ADHESIONS FOR A PELVIC MASS, POLYCYSTIC OVARIAN SYNDROME, HISTORY OF ENDOMETRIOSIS WITH DYSFUNCTIONAL UTERINE BLEEDING AND CHRONIC PELVIC PAIN ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: FOLLOW-UP (FU) VISIT WITH HISTORY AND PHYSICAL (H&P) (B)(6) 2012. 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. INTRAOPERATIVELY, AN EXTENSIVE ADHESIVE DISEASE WAS OBSERVED WITH MOSTLY FILMY ADHESIONS INVOLVING THE SMALL BOWEL AND THE RIGHT TUBE AND OVARY, THE RECTOSIGMOID COLON AND THE POSTERIOR ASPECT OF THE UTERUS, AS WELL AS THE SMALL BOWEL AND THE FUNDUS OF THE UTERUS. THERE WERE SOME ADHESIONS FROM THE LEFT TUBE AND OVARY TO THE RECTOSIGMOID COLON AS WELL. THE CUL-DE-SAC HAD PREVIOUSLY BEEN OBLITERATED WITH ENDOMETRIOSIS AND HERE WAS STILL SCARRING AND NODULARITY ALONG THE UTEROSACRALS AND CUL-DE-SAC PERITONEUM. THERE WAS A CYSTIC MASS ARISING FROM THE RIGHT OVARY AND EVIDENCE OF ENDOMETRIOSIS ON BOTH OVARIES. FOR THE ROBOTIC PART OF THE SURGERY MONOPOLAR SCISSORS, BIPOLAR CAUTERY AND THE PROGRASP WERE USED. THE UTERUS WAS MOBILIZED, THE BLADDER TAKEN DOWN AND A COLPOTOMY PERFORMED. THE SPECIMEN WAS DELIVERED THROUGH THE VAGINA. HEMOSTASIS WAS OBTAINED OF THE VAGINAL CUFF. THE VAGINAL CUFF WAS THEN CLOSED WITH 0 VICRYL SUTURE IN A RUNNING LOCKING FASHION. URETERS WERE CAREFULLY EXAMINED AND NOTED TO BE CLEAR FROM INJURY. AFTER AN UNEVENTFUL INITIAL POSTOPERATIVE COURSE THE PATIENT WAS SEEN FOR A FOLLOW UP VISIT ON (B)(6) 2012 AND PRESENTED WITH ABDOMINAL PAIN, NAUSEA, REFERRED PAIN, URINARY DIFFICULTY, ANXIETY AND SWEATING WITH HOT FLASHES. A POSTOPERATIVELY PERFORMED CT SCAN THROUGH THE EMERGENCY DEPARTMENT (ED) FOR LUMBAR PAIN SHOWED A POSTSURGICAL FLUID COLLECTION WITH SOME MINIMAL STRANDING. ON (B)(6) 2012, SHE PRESENTED WITH BILATERAL LOWER QUADRANT ABDOMINAL DISCOMFORT, PRESENT SINCE 6 DAYS AND MILD BILATERAL LOWER EXTREMITY LYMPHEDEMA. AN ASSOCIATED FULLNESS AND PAIN AT THE VAGINAL CUFF WAS OBSERVED AND THE PATIENT TREATED EMPIRICALLY FOR PRESUMED LOCALIZED CUFF INFECTION. DURING THE FOLLOW-UP VISIT ON (B)(6) 2012, THE PATIENT PRESENTED WITH IMPROVED OVERALL STATUS AND HER ACTIVITY LEVEL WAS BACK TO PRE-OPERATIVE LEVEL. THE VAGINAL DISCHARGE IMPROVED; HOWEVER, SHE CONTINUED TO HAVE SOME DYSURIA AT TIMES WITH STRESS INCONTINENCE. DURING THE FOLLOW-UP VISIT ON (B)(6) 2012 SHE PRESENTED AGAIN WITH SUBFEBRILE TEMPERATURE AND DISCREET ABDOMINAL PAIN A,ND BUT CONTINUES TO HAVE OCCASIONAL VAGINAL DISCHARGE AND URINARY INCONTINENCE. THE INTERNAL GYNECOLOGICAL EXAM REVEALED A CUFF SEPARATION WITH PURULENT DRAINAGE. AN ADDITIONAL CT WAS DISCUSSED AS WELL AS RE-INITIATION OF THE ANTIBIOTIC THERAPY. NO FURTHER INFORMATION OR STATUS REPORT WAS AVAILABLE." }, { "mdr_text_key": "11248103", "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 COMPLICATION(S) 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 POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI 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": "" } ] }