{ "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": "2955842-2013-04933", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20070720", "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": "563009", "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 A6.0P8", "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": [ "Cut In Material" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "38 YR", "patient_sex": "", "patient_weight": "54", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Granuloma", "Hemorrhage/Blood Loss/Bleeding", "Pain", "Discharge" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444179", "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": "11244438", "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." }, { "mdr_text_key": "3948247", "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 FOR DYSFUNCTIONAL UTERINE BLEEDING, METRORRHAGIA AND CHRONIC PELVIC PAIN ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH 2 OPERATIVE REPORTS. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL - (B)(6) 2007. DISCHARGE SUMMARY (B)(6) 2007, GYN CONSULTATION (B)(6) 2007, NURSING ADMISSION H&P (B)(6) 2007, PROGRESS NOTE (B)(6) 2007. 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. AFTER PLACEMENT OF A UTERINE MANIPULATOR, DEVELOPMENT OF A PNEUMOPERITONEUM THROUGH AN INFRAUMBILICAL INCISION THE ROBOT WAS DOCKED TO THE PREVIOUSLY PLACED PORTS. THE HYSTERECTOMY WAS CARRIED OUT IN A STANDARD FASHION. THE LATERAL PELVIC LIGAMENTS TO THE UTERUS WERE CAUTERIZED AND CUT BILATERALLY USING THE CUTTING BIPOLAR AND THE SPATULA. THE BLADDER FLAP WAS DEVELOPED AND THE UTERINE VESSELS SKELETONIZED BILATERALLY. A CIRCUMFERENTIAL COLPOTOMY WAS CARRIED OUT USING SPATULA AND ELECTROCAUTERY AND THE SPECIMEN REMOVED THROUGH THE VAGINA. THE CUFF WAS CLOSED WITH O VICRYL SUTURE IN 2 RUNNING CONTINUOUS STITCHES, AND THESE WERE CLIPPED AT THE MIDLINE USING AN ENDOCLIP. THE PATIENT WAS DISCHARGE HOME AFTER AN UNREMARKABLE POSTOPERATIVE COURSE ON (B)(6) 2007. THE PATIENT WAS READMITTED ON (B)(6) 2007 FOR EVALUATION OF VAGINAL BLEEDING AND DISCHARGE AND LOW GRADE TEMPS. A CT ABDOMEN/PELVIS PERFORMED THAT DAY, DEMONSTRATED A 2.5 X 4.5 CM VAGINAL CUFF ABSCESS AND THE PATIENT WAS PLACE ON IV ANTIBIOTIC THERAPY. AFTER QUICK IMPROVEMENT OF CLINICAL AND LABORATORY PARAMETERS SHE WAS DISCHARGE HOME ON (B)(6) 2007. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2007 FOR SEVERE PAIN AND HEAVY BLEEDING AFTER INTERCOURSE. EVALUATION REVEALED A SMALL AMOUNT OF GRANULATION TISSUE AT THE VAGINAL CUFF AND A VAGINAL CUFF LACERATION WAS QUESTIONED. SHE UNDERWENT A CT SCAN WHICH SHOWED INTERVAL IMPROVEMENT SINCE HER LAST SCAN IN AUGUST BUT THERE WAS A VERY SMALL FLUID COLLECTION ADJACENT TO THE RECTUM AND SOME PERSISTENT STRANDING AND INFLAMMATORY CHANGES WITHIN THE PELVIS. THEREFORE, SHE WAS TREATED WITH IV ANTIBIOTICS AND DISCHARGED IN GOOD CONDITIONS ON (B)(6) 2007. ON (B)(6) 2007, SHE WAS READMITTED FOR OPERATIVE CUFF REVISION AND UNDERWENT A LAPAROSCOPY WITH ADHESIOLYSIS, CYSTOSCOPY AND CUFF REVISION FOR CUFF LACERATION, DYSPAREUNIA AND COLON ADHESIONS TO THE VAGINAL CUFF. THE CUFF RENT WAS NOTED AND THE EDGES OF THE TEAR IN THE CUFF WERE EXCISED AND THEN THE CUFF WAS CLOSED WITH ABOUT 9 SUTURES OF ZERO VICRYL IN INTERRUPTED SUTURES TO CLOSE THE LACERATION IN THE CUFF. IN A FOLLOW-UP VISIT ON (B)(6) 2007, SHE CONTINUED TO HAVE SOME PAIN WHICH WAS IMPROVING. SHE DID NOT HAVE ANY FEVER." } ], "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": "" } ] }