{ "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": "2955842-2012-01468", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20121228", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "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": [ "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20121231", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121228", "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": "N", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20121228", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20121128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2889862", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121128", "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": "3059913", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, A BOWEL PERFORATION WAS DISCOVERED POST SURGERY. THE SURGEON REPORTEDLY STATED THAT THE INJURY MAY HAVE OCCURRED WHILE INSERTING THE CAMERA CANNULA, OR WHEN CUTTING THROUGH THE FASCIA. NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENT(S) AND/OR ACCESSORIES WERE REPORTED DURING THE COURSE OF THIS PROCEDURE." }, { "mdr_text_key": "10368034", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ACCORDING TO FOLLOW UP INFORMATION OBTAINED ON (B)(4) 2012 FROM THE CLINICAL SALES REPRESENTATIVE WHO WAS PRESENT DURING THE SURGERY, THERE WERE NO PATIENT COMPLICATIONS OBSERVED DURING THE CASE. THE BOWEL PERFORATION WAS DISCOVERED AFTER THE PATIENT PRESENTED WITH PAIN AT THE EMERGENCY ROOM, AFTER WHICH A SECONDARY, NON-ROBOTIC PROCEDURE WAS CONDUCTED TO TREAT THE INJURY. THE SURGEON BELIEVES THE PERFORATION MAY HAVE OCCURRED WHEN THE CAMERA CANNULA WAS INSERTED, OR WHEN CUTTING THROUGH THE FASCIA. THE PATIENT HAS SINCE RECOVERED AND IS DOING WELL. NO FURTHER INFORMATION WAS AVAILABLE. THERE WERE NO REPORTS OF ANY MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, AND THE HOSPITAL HAS CONTINUED TO USE THE SYSTEM TO PERFORM SURGERY ON PATIENTS. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS TO MINIMIZE THE RISKS ASSOCIATED WITH PORT PLACEMENT, ENSURE THE FOLLOWING: APPROPRIATE PATIENT POSITIONING TO SHIFT ORGANS AWAY FROM THE PORT PLACEMENT SITE. AN ADEQUATE LEVEL OF INSUFFLATION. OBTURATOR TIP IS POINTING AWAY FROM MAJOR VESSELS, ORGANS, AND OTHER ANATOMIC STRUCTURES. WHEN POSSIBLE, VISUALIZATION OF THE ENTIRE INSERTION OF THE CANNULA USING THE ENDOSCOPE IS PREFERRED. MODERATE, CONTROLLED PRESSURE IS EMPLOYED WHEN PLACING THE CANNULA AND OBTURATOR. AS OF (B)(4) 2012, THERE WERE NO REPORTS OF THE SAME RECURRENCE AT THE THIS HOSPITAL." } ], "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": "" } ] }