{ "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": "2955842-2013-04934", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120730", "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": "562159", "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 A5.1P8", "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": "20250805", "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": "65 YR", "patient_sex": "", "patient_weight": "64", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444191", "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": "15419775", "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 SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL PROCEDURE." }, { "mdr_text_key": "15018528", "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 EXTRAFASCIAL TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC AND PARAORTIC NODE DISSECTION FOR AN UNSTAGED ADENOCARCINOMA OF THE ENDOMETRIUM ON (B)(6) 2012. IN ADDITION, THE PATIENT ALSO UNDERWENT A DIAGNOSTIC LAPAROSCOPY AND WASHINGS. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (B)(6) 2012, HANDWRITTEN (B)(6) 2012, DISCHARGE SUMMARY (B)(6) 2012 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. A DIAGNOSTIC LAPAROSCOPY REVEALED A BENIGN UPPER ABDOMEN, BOWEL, AND RETROPERITONEUM. THERE WAS NO OBVIOUS EVIDENCE OF EXTRAUTERINE DISEASE. THE ROBOT WAS DOCKED AND THE UTERUS WAS MOBILIZED BY ISOLATING AND DIVIDING THE BILATERAL LIGAMENTS OF THE UTERUS, THE INFUNDIBULOPELVIC LIGAMENTS AND THE PERITONEUM AROUND IT. THE URETERS WERE IDENTIFIED. THE UTEROVESICAL FOLD WAS DIVIDED AND THE BLADDER PROGRESSIVELY DISSECTED OFF THE LOWER UTERINE SEGMENT TO APPROXIMATELY 2CM BELOW THE CERVICOVAGINAL JUNCTION. AFTER COLPOTOMY THE SPECIMEN WAS EXTRACTED FROM THE PERITONEAL CAVITY. THE RIGHT AND LEFT PERIVESICAL AND PERIRECTAL SPACES WERE DEVELOPED, THE ILEOCECUM AND RECTOSIGMOID MOBILIZED AND A LYMPHADENECTOMY PERFORMED BILATERAL LOW AND PARAORTIC. THE CUFF WAS THEN CLOSED USING RUNNING BULK CLOSURE USING 0 V-LOC. AFTER AN UNEVENTFUL POSTOPERATIVE COURSE THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. THE PATIENT WAS READMITTED ON (B)(6) 2012 AS TRANSFER FROM AN EXTERNAL HOSPITAL AFTER SHE WAS FOUND TO HAVE A VAGINAL CUFF DEHISCENCE FOLLOWING INTERCOURSE. THE PATIENT ARRIVED AT A HOSPITAL ASSESSMENT CENTER THE EVENING OF (B)(6) 2012, WAS EVALUATED, AND CONFIRMED TO HAVE A VAGINAL CUFF DEHISCENCE. SHE WAS TAKEN TO THE OPERATING ROOM WHERE REPAIR WAS PERFORMED. INTRAOPERATIVELY, THE CUFF WAS NOTED TO BE DEHISCED ALONG THE SURGICAL SCAR. BOWEL WAS IDENTIFIED TO BE WITHIN THE ABDOMINAL CAVITY. THERE WAS VERY LITTLE BLEEDING FROM THE EDGES OF THE DEHISCED WOUND. ANTERIOR AND POSTERIOR ASPECTS OF THE VAGINAL CUFF WERE THEN GRASPED AND THE SCAR EDGES WERE FRESHENED UP AND A 0 VICRYL RUNNING INTERLOCK SUTURE WAS THEN USED ALONG THE POSTERIOR ASPECT OF THE CUFF AND A SEPARATE 0 VICRYL SUTURE WAS USED ALONG THE ANTERIOR ASPECT OF THE CUFF CLOSING THE ANTERIOR AND POSTERIOR EDGES TOGETHER IN A RUNNING LOCKED FASHION. THE PATIENT RECOVERED FAST FROM SURGERY AND WAS DOING VERY WELL THE NEXT MORNING. SHE WAS DISCHARGED HOME ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." } ], "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": "" } ] }