{ "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": "2955842-2012-00319", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20120706", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120613", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120807", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120706", "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 A6.0P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Physical Resistance" ], "reporter_state_code": "IA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20120706", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20130107", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2644122", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120613", "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": "20092836", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, USING DUAL SURGEON SIDE CONSOLES (SSC) THE SURGEON WORKING FROM SSC 1 EXPERIENCED RESISTANCE WHILE MANIPULATING THE MASTER TOOL MANIPULATORS (MTM) AND WHEN THE SURGEON LET GO OF THE MTMS ON THE SSC1 THE PATIENT'S ABDOMINAL WALL WAS DAMAGED. THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING (TSE) FOR TROUBLE-SHOOTING ASSISTANCE. WITH THE ASSISTANCE OF THE TSE, THE SITE SWITCHED FROM DUAL SSC SETUP TO SINGLE SSC SETUP TO PROCEED WITH THE PLANNED SURGICAL PROCEDURE. RESISTANCE ON THE SSC 2 MTMS WAS NOT EXPERIENCED BY THE SURGEON. THE TSE ASKED THE INITIAL REPORTER IF THE SURGEON WORKING FROM SSC1 HAD REMOVED HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV) PRIOR TO RELEASING THE HIS HANDS FROM THE MTMS; HOWEVER, THE SURGICAL STAFF WAS UNABLE TO PROVIDE THIS INFORMATION. REVIEW OF THE SITE'S SYSTEM LOG BY THE TSE FOUND RECOVERABLE SYSTEM ERROR CODE 23002 OCCURRED ON THE MTMR AT THE TIME OF THE CUSTOMER'S REPORT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "20210332", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE FIELD INVESTIGATION CONDUCTED BY THE ISI FSE CONCERNING THIS EVENT WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. HOWEVER, AFTER MANIPULATING THE MTM ON SSC1 THE FSE WAS ABLE TO INDUCE THE RECOVERABLE SYSTEM ERROR CODE 23002 AND CONCLUDED THAT THE SYSTEM ERROR CODE WAS RELATED TO THE MTMR; HOWEVER, HE DID NOT NOTE ANY RESISTANCE ON THE MTMR OR THE PATIENT SIDE MANIPULATORS. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE REPORTED RESISTANCE FROM THE SURGEON AND THE 23002 ARE BOTH CONSISTENT WITH AN INACCURATE CALIBRATION, SINCE THE GRAVITY COMPENSATION ALGORITHM ON THE MASTER RELIES ON AN ACCURATE MEASUREMENT OF THE ARM POSITION. GRAVITY COMPENSATION IS PROVIDED FOR THE COMFORT OF THE SURGEON AND IS NOT INTENDED TO ALLOW THEM TO RELEASE THEIR GRIP ON THE MASTER WHILE IN FOLLOWING. AS A PRECAUTION, THE FSE CALIBRATED THE MTMS ON SSC 1. THE PATIENT INJURY MOST LIKELY OCCURRED AS A RESULT OF THE SURGEON'S REMOVAL OF HIS HANDS FROM THE MTMS PRIOR TO REMOVAL OF HIS HEAD FROM THE HIGH RESOLUTION STEREO VIEWER. THE DA VINCI SI USER MANUAL WARNING(S) SPECIFICALLY STATES: ONCE IN FOLLOWING, THE SURGEON CONSOLE OPERATOR MUST NOT REMOVE IS OR HER HANDS FROM THE MASTERS UNTIL REMOVING HIS OR HER HEAD FROM THE SURGEON CONSOLE VIEWER-THEREBY TAKING THE SYSTEM OUT OF FOLLOWING MODE. FAILURE TO DO SO MAY RESULT IN UNCONTROLLED MOVEMENT OF THE MASTERS, RESULTING IN SERIOUS HARM TO THE PATIENT. THE PREVIOUS CALIBRATION OF THE MTM OCCURRED ON JUNE 12, 2012 DURING A ROUTINE PREVENTATIVE MAINTENANCE (PM) ON THE SITE'S SYSTEM. THE FSE REPORTED ISSUES WITH HIS LAPTOP WHILE CALIBRATING THE MASTER TOOL MANIPULATOR (MTMS) ON SSC 1. WITH THE ASSISTANCE OF ISI DVSTAT SUPPORT, IT WAS DETERMINED THAT THE FSE'S LAPTOP HAD MALFUNCTIONED AND THE CALIBRATION FILES WERE RESTORED TO SITE'S SYSTEM. A SINE CYCLE AND TEST DRIVE OF THE SYSTEM WAS PERFORMED BY THE FSE FOUND THAT THE SYSTEM PERFORMED WITHIN SPECIFICATION. ISI HAS MADE SEVERAL ATTEMPTS TO VERIFY THE STATUS OF THE PATIENT. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS PROVIDED. AS OF JULY 6, 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." }, { "mdr_text_key": "17351263", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INITIAL MDR WAS INADVERTENTLY SENT WITH INCORRECT INFORMATION: TYPE OF REPORTABLE EVENT." } ], "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": "01/07/2013" } ] }