{ "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": "2955842-2013-03480", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130911", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120612", "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": "456383", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130911", "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": [ "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": "20250804", "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 SUR SYS. INSTRMNTS, ACCESSIES & ESU." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "144", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Chest Pain", "Dyspnea", "Pulmonary Emphysema", "Granuloma", "Hemorrhage/Blood Loss/Bleeding", "Pain", "Extubate", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3343053", "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": "3812735", "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 AND THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012, WITH A PRE-OPERATIVE DIAGNOSIS OF MENORRHAGIA, LEIOMYOMATA UTERI AND COMPLEX OVARIAN MASS. ACCORDING TO THE PATIENT'S OPERATIVE (OP REPORT) THERE WERE NO ANOMALIES NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. REPORTEDLY, AT THE END OF THE SURGICAL PROCEDURE, THE ENTIRE SURGICAL AREA WAS INSPECTED FOR HEMOSTASIS AND THERE WAS NO EVIDENCE OF BLEEDING. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE PAR IN STABLE CONDITION. REPORTEDLY, DURING HOSPITALIZATION THE PATIENT COMPLAINED OF CHEST PAIN, SHORTNESS OF BREATH AND ABDOMINAL PAIN AND ON (B)(6) 2012. A CHEST CT SCAN SHOWED NO EVIDENCE OF PULMONARY EMBOLISM. ON (B)(6) 2012, THE PATIENT UNDERWENT AN ABDOMINAL AND PELVIS CT SCAN. THE CT SCAN SUGGESTED SUBCUTANEOUS EMPHYSEMA AND PNEUMOPERITONEUM WITH SMALL BOWEL PERFORATION. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON (B)(6) 2012 AND NOTED TO HAVE A 2MM DEFECT IN THE TRANSVERSE COLON WHICH WAS EXCISED AND CLOSED WITH NO SIGNS OF LEAK. THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL AND THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT. PER THE INFORMATION PROVIDED, THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA RECOVERY INTUBATED AND IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT'S POST-SURGICAL RECOVERY WAS UNREMARKABLE. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, DURING A ROUTINE POST-OPERATIVE VISIT ON (B)(6) 2012, THE PATIENT WAS FOUND TO HEALING WELL AND THE PATIENT'S BLADDER AND BOWL FUNCTION WAS RETURNING TO NORMAL. THERE WAS NO INDICATION THAT THE PATIENT HAD ANY RECURRING POST-SURGICAL COMPLICATIONS. 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 BLED 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 MEDICAL 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": "11197639", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED IN THE 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. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BOWEL INJURY DURING A DA VINCI SI HYSTERECTOMY 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": "" } ] }