{ "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": "2955842-2014-05895", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141219", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20141121", "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": [ "Invalid data" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20141222", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "835518", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141219", "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": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20141203", "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": "MS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20141219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20141121", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4348286", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141121", "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": "5139591", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON 11/21/2014, THE PATIENT LOST TOO MUCH BLOOD FROM A PUMPING BLOOD VESSEL. DUE TO THE VESSEL ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI SURGICAL PROCEDURE AND ENTER VAGINALLY. THE CAUSE OF THE BLEEDING VESSEL WAS NOT PROVIDED. ALSO, DURING THE SURGICAL PROCEDURE, THE INITIAL REPORTER INDICATED THAT THE SURGICAL STAFF ENCOUNTERED A BLADE EXPOSED MESSAGE INVOLVING THE USE OF A VESSEL SEALER INSTRUMENT. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR WAS NOT PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. BASED ON HIS COMMUNICATIONS WITH THE SITE, THE CSR WAS INFORMED THAT THE SURGICAL STAFF ENCOUNTERED A BLEEDING VESSEL TOWARDS THE END OF THE DA VINCI SURGICAL PROCEDURE. SINCE THE SURGEON WAS UNABLE TO USE THE VESSEL SEALER INSTRUMENT AT THE TIME, THE SURGEON MADE THE DECISION REMOVE THE DA VINCI INSTRUMENTS AND TO STOP THE VESSEL FROM BLEEDING BY ENTERING VAGINALLY. THE CSR DID NOT KNOW THE CAUSE OF THE BLEEDING VESSEL. THERE IS NO ALLEGATION THAT THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE BLEEDING VESSEL EXPERIENCED BY THE PATIENT." }, { "mdr_text_key": "12622358", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE VESSEL SEALER INSTRUMENT (PART 410322-05; LOT M10141001 282) INVOLVED WITH THIS COMPLAINT WAS RETURNED ISI AND EVALUATED. FAILURE ANALYSIS (FA) OF THE INSTRUMENT CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF AN EXPOSED BLADE. THE BLADE OF THE VESSEL SEALER INSTRUMENT WAS FOUND TO BE DISLODGED BETWEEN THE GRIPS. A SELF-TEST DID NOT PASS AND THE VESSEL SEALER INSTRUMENT WOULD NOT ENGAGE. NEITHER THE BLADE CABLE NOR BLADE WAS FOUND TO BE BENT. AFTER RE-SEATING THE BLADE, THE INSTRUMENT PASSED A SELF-TEST. ELECTRICAL CONTINUITY TESTING OF THE INSTRUMENT PASSED. NO OTHER INSTRUMENT DAMAGE WAS FOUND. THE REPORTED COMPLAINT OF ENCOUNTERING A BLADE EXPOSED MESSAGE DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT. FAILURE ANALYSIS CONCLUDED THAT THE EXPOSED BLADE WAS CAUSED BY USER MISHANDLING, WITH THE VESSEL SEALER INSTRUMENT JAWS BEING OPENED TOO WIDE ALLOWING THE BLADE TO TWIST AND POSSIBLY DERAIL AND OR THE CUT FUNCTION BEING ACTIVATED ON A HARD SURFACE CAUSING THE KNIFE TO BEND AND NOT RETURN INTO THE INSTRUMENT AS INTENDED. RECURRENCE OF THE REPORTED COMPLAINT AND OBSERVED FAILURE MODE ARE NOT EXPECTED TO LIKELY CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014 REVEALED THAT FOUR SYSTEM ERROR CODE 32001'S OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF WAS ABLE TO OVERRIDE THE SYSTEM ERROR CODE EACH TIME. A SYSTEM ERROR CODE 32001 SIGNIFIES THAT THE BLADE OF THE VESSEL SEALER INSTRUMENT COULD NOT BE RETRACTED AND MAY BE EXPOSED. IN ADDITION, AT ONE POINT DURING THE SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A SYSTEM ERROR CODE 32003 WHICH SIGNIFIES THAT THE VESSEL SEALER INSTRUMENT WAS NOT ABLE TO DRIVE THE CUTTING BLADE ACROSS THE FULL RANGE OF TRAVEL DURING A CUT COMMAND. THIS COULD BE CAUSED BY A DIRTY VESSEL SEALER INSTRUMENT OR ATTEMPTING TO CUT VERY THICK AND/OR UNSEALED TISSUE. ALSO, THE SURGICAL STAFF ENCOUNTERED TWO SEPARATE SYSTEM ERROR CODE 100 POINTING TO THE CAMERA SETUP JOINT (SUJC) AND SETUP JOINT 1 (SUJ1). THE SYSTEM ERROR CODE 100'S LIKELY OCCURRED WHILE THE USER(S) WERE ATTEMPTING TO MOVE THE SUJS WITHOUT PRESSING THE SUJ BUTTON. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED A BLEEDING VESSEL WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI SURGICAL PROCEDURE AND CONTROLLED THE BLEEDING VESSEL VAGINALLY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED THE BLEEDING VESSEL EXPERIENCED BY THE PATIENT." } ], "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": "" } ] }