{ "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": "2955842-2013-04950", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20090715", "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": "562994", "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 A5.1P7", "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 S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "49 YR", "patient_sex": "", "patient_weight": "88", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pain", "Urinary Tract Infection", "Organ Dehiscence" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444233", "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": "3901080", "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 S TOTAL LAPAROSCOPIC HYSTERECTOMY FOR ABNORMAL UTERINE BLEEDING AND FIBROIDS ON (B)(6) 2009. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT (B)(6) 2009. ADDITIONAL INFORMATION PROVIDED INCLUDES HISTORY AND PHYSICAL (H&P) (B)(6) 2009. OUTPATIENT FOLLOW-UP (F/U) NOTE (B)(6) 2009, EMERGENCY DEPARTMENT NOTE (B)(6) 2009 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 OPERATION WAS INITIATED WITH PLACEMENT OF A RUMI UTERINE MANIPULATOR. PNEUMOPERITONEUM WAS CREATED WITH THE VERESS NEEDLE THROUGH A PREVIOUS LAPAROSCOPIC INCISION. PORTS WERE PLACED AND THE ROBOT WAS DOCKED. USING THE BIPOLAR FORCEPS AND THE MONOPOLAR SCISSORS, THE UTERUS WAS MOBILIZED CIRCUMFERENTIALLY, INCLUDING DISSECTION OF BILATERAL LIGAMENTS; TAKE DOWN OF THE BLADDER FLAP, SKELETONIZATION AND BIPOLAR FULGURATION OF UTERINE ARTERIES. AN ADDITIONAL UTERINE BRANCH IN THE LEFT HEMIPELVIS WAS BLEEDING, WHICH WAS CONTROLLED WITH THE BIPOLAR FORCEPS. COLPOTOMY WAS CARRIED OUT WITH MONOPLAR SCISSORS AND THE SPECIMEN REMOVED TRANSVAGINALLY. THE VAGINAL ANGLES WERE CLOSED WITH FIGURE-OF-EIGHT SUTURES OF NUMBER 1 VICRYL. THE VAGINAL CUFF WAS CLOSED WITH A SERIES OF FIGURE-OF-EIGHT SUTURES OF NUMBER 1 VICRYL, AS WELL. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2009 PATIENT PRESENTED AT ED FOR PAIN AND PRESSURE IN THE PELVIS WITH THE FEELING SOMETHING IS COMING FROM THE VAGINA. THE PATIENT RECEIVED TREATMENT FOR A UTI. ON (B)(6) 2009 PATIENT PRESENTED AGAIN AT ED AND WAS TOLD SHE HAD HEMORRHOIDS ON (B)(6) 2009 F/U WITH GYN WHERE SMALL BOWEL WAS NOTED PROTRUDING THROUGH THE CUFF. ON (B)(6) 2009 EXAMINATION UNDER ANESTHESIA WITH DEBRIDEMENT OF VAGINAL CUFF AND SECONDARY CLOSURE OF VAGINAL CUFF DEHISCENCE WAS PERFORMED FOR VAGINAL CUFF DEHISCENCE WITH TRANSVAGINAL EVISCERATION. THERE WERE NO LOOPS OF BOWEL ADHERENT TO THE VAGINAL CUFF OR POSTERIOR PERITONEUM OR CUL-DE-SAC, NOR ANTERIORLY OVER THE PERITONEUM OVERLYING THE BLADDER. VAGINAL CUFF WAS DEBRIDED OF A SMALL AMOUNT OF NON-BLEEDING TISSUE. A MINI-LAPAROTOMY SPONGE WAS PLACED INTO THE PERITONEUM TO ELEVATE THE BOWEL, VAGINAL ANGLES WERE CLOSED WITH FIGURE-OF-EIGHT SUTURES OF 1 VICRYL, THE PERITONEUM WAS CLOSED, AND THE VAGINAL CUFF WAS CLOSED WITH A SERIES OF FIGURE-OF-EIGHT SUTURES OF 1 VICRYL. EXCELLENT REAPPROXIMATION WAS ACHIEVED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF THE 2ND OPERATION." }, { "mdr_text_key": "11372569", "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 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": "" } ] }