{ "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": "2955842-2013-03479", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130911", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20121017", "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": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "456382", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130911", "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": "DA", "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": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20130911", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "35 YR", "patient_sex": "", "patient_weight": "78", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Hemorrhage/Blood Loss/Bleeding", "Pain" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3343050", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "3812734", "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 INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY AND BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF ABNORMAL UTERINE BLEEDING AND PELVIC PAIN. THERE WAS NO INDICATION IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE INFORMATION PROVIDED IN THE OP REPORT ON (B)(6) 2012, AFTER THE PATIENT'S VAGINAL CUFF WAS CLOSED, GOOD HEMOSTASIS WAS NOTED. A CYSTOSCOPY WAS ALSO PERFORMED SHOWED THE PATIENT'S BLADDER WAS INTACT. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. REPORTEDLY, DURING A ROUTINE POST-OPERATIVE CHECKUP ON (B)(6) 2013, THE PATIENT COMPLAINED OF EXPERIENCING ABDOMINAL PAIN AND PAIN AROUND HER UMBILICUS. THE PATIENT ALSO COMPLAINED OF RECTAL BLEEDING. SHE WAS SUGGESTED TO STOP HER ESTROGEN AND START DEPO PROVERA. ON (B)(6) 2013, THE PATIENT RETURNED TO HER PHYSICIAN BECAUSE SHE WAS EXPERIENCING HEAVY BLEEDING AND RIGHT-SIDED PELVIC AND ABDOMINAL PAIN. THE PATIENT'S POST-OPERATIVE DOCUMENTATION INDICATED THAT THE PATIENT HAD AN AREA ABOUT 3CM LONG AT THE TOP OF HER VAGINAL VAULT THAT LOOKED LIKE GRANULATION TISSUE OR A FALLOPIAN TUBE. THE AREA WAS VERY TENDER FOR THE PATIENT AND BLEED EASILY WHEN TOUCHED. NO FURTHER INFORMATION ABOUT THIS VISIT WAS PROVIDED TO ISI. REPORTEDLY, THE PATIENT UNDERWENT A CT SCAN ON (B)(6) 2013. THE CT SCAN SHOWED THICKENING OF HER TRANSVERSE COLON AND DESCENDING COLON. THE PATIENT UNDERWENT A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE PATIENT OP REPORT, THE PATIENT'S RECTUM APPEARED NORMAL; HOWEVER, THE ANORECTAL AREA SHOWED A GRADE I-II INTERNAL HEMORRHOIDS AND ALSO HYPERTROPHIC ANAL PAPILLA. A PERIANAL EXAMINATION ALSO FOUND THAT THE PATIENT HAD EXTERNAL HEMORRHOIDS. A DIGITAL EXAMINATION FOUND THAT THE ANAL CANAL APPEARED NORMAL. ACCORDING TO THE MEDIAL RECORDS PROVIDED TO ISI, ON (B)(6) 2013 THE PATIENT UNDERWENT A BIOPSY OF GRANULATION TISSUE OF THE VAGINAL VAULT. THE AFFECTED AREA WAS CAUTERIZED AND THERE WAS NO FURTHER BLEEDING NOTED. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE POST-ANESTHESIA RECOVERY ROOM IN SATISFACTORY CONDITION. ACCORDING TO THE PATHOLOGY RESULTS OF THE BIOPSIED TISSUE, THE DIAGNOSIS WAS ACUTE AND ORGANIZING ABSCESS TISSUE AND NEGATIVE FOR MALIGNANCY. ON (B)(6) 2013, THE PATIENT UNDERWENT A ROUTINE POST-SURGICAL FOLLOW-UP. THE PATIENT HAD PELVIC PAIN WITH AN UNKNOWN CAUSE. THE PATIENT WAS THEN REFERRED TO A SPECIALIST FOR FURTHER EVALUATION. PATIENT INFORMATION SINCE THEN WAS NOT PROVIDED." }, { "mdr_text_key": "11197638", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS POST A DA VINCI HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "34337240", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "." } ], "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": "03/19/2015" } ] }