{ "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": "2955842-2013-02170", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130614", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130515", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130614", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "271885", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130614", "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": "Yes", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20130614", "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": [ "Injury" ] } ], "distributor_city": "", "date_report": "20130515", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3170123", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130515", "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": "10851619", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON CONTACTED ISI AND PROVIDED THE FOLLOWING INFORMATION: THE SURGEON INDICATED THAT HIS HEAD WAS WITHIN THE HIGH RESOLUTION STEREO VIEWER (HRSV) AND HE WAS GRASPING BOTH MASTER TOOL MANIPULATORS (MTM'S) WHEN THE PATIENT SIDE MANIPULATOR (PSM1; RIGHT ARM) JERKED AWAY FROM HIM. HE DENIED MOVING THE PSM OR THE MTM'S AT THE TIME OF THE EVENT. HE ALSO STATED THAT THE PSM1 WAS NOT TOUCHING ANY OTHER INSTRUMENT WHEN THE EVENT OCCURRED. DUE TO THE INADVERTENT MOVEMENT, THE SURGEON INDICATED THAT A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INSTALLED ON PSM1 PERFORATED THE PATIENT'S BOWEL. THE SURGEON INDICATED THAT THE BOWEL INJURY WAS 1 CM IN SIZE. HE REPAIRED THE INJURY BY USING THE DA VINCI SI SURGICAL SYSTEM AND BY SUTURING. THE SURGEON INDICATED THAT AFTER THE EVENT OCCURRED, HE CONTINUED TO USE PSM1 AND COMPLETED THE SURGICAL PROCEDURE WITH NO FURTHER ISSUES REPORTED. THE SURGEON DENIED THAT THE PATIENT EXPERIENCED ANY POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "3548793", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF INDICATED THAT THE PATIENT SIDE MANIPULATOR (PSM1) ARM 1 MOVED INADVERTENTLY AND THE PATIENT SUSTAINED A BOWEL INJURY. THE SURGEON REPAIRED THE BOWEL INJURY AND THE SURGICAL PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "10785416", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, AN INTUITIVE SURGICAL (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION OF THE DA VINCI SI SURGICAL SYSTEM AT THE SITE. BASED ON THE FSE'S EVALUATION, THE SYSTEM TESTED TO MANUFACTURER SPECIFICATIONS AND THE FSE OBSERVED A CASE THAT DAY AND NO ERRORS WERE OBSERVED. ON (B)(4) 2013, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE EVENT: THE SURGICAL PROCEDURE WAS NOT RECORDED. AN UNSPECIFIED SCISSOR INSTRUMENT MOVED FORWARD WHICH RESULTED WITH THE PATIENT'S BOWEL SUSTAINING A PERFORATION INJURY. THE CSR WAS UNABLE TO EXPLAIN HOW OR WHY THE INSTRUMENT MOVED FORWARD. HE ALSO DID NOT KNOW IF THE SURGEON'S HEAD WAS WITHIN THE HIGH RESOLUTION STEREO VIEWER (HRSV) OR IF HE WAS GRASPING THE MASTER TOOL MANIPULATORS (MTM) WHEN THE EVENT OCCURRED. THE CSR INDICATED THAT THE SURGEON WAS ABLE TO REPAIR THE PATIENT'S BOWEL INJURY USING THE DA VINCI SYSTEM AND THE PROSTATECTOMY PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES REPORTED. THE CSR STATED THE SURGEON HAD GOTTEN MULTIPLE INFORMATIONAL MESSAGES DURING THE PROCEDURE STATING RELAX YOUR GRASP ON THE MASTER SO THAT IT CAN SELF-ALIGN AND THE SURGEON IGNORED THEM. THE CSR INSTRUCTED THE SURGEON NOT TO IGNORE THESE SYSTEM MESSAGES IN FUTURE SURGICAL PROCEDURES. THE SURGEON INFORMED THE CSR THAT THE PATIENT SIDE MANIPULATOR (PSM) ARM MOVED AS HE WAS WORKING AT THE END OF THE CANNULA. THE CSR INSTRUCTED THE SURGEON ON NOT WORKING AT THE END OF THE CANNULA TO HAVE FULL RANGE OF MOTION WITH INSTRUMENTS. ON (B)(4) 2013, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT OF THE SITE AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013, AND THE PATIENT DID NOT SUSTAIN ANY POST-OPERATIVE COMPLICATIONS. THE RISK MANAGEMENT DEPARTMENT READ THE OPERATIVE NOTES AND THE SURGEON NOTED, THE ARMS GOT AWAY FROM ME AND HE COULD NOT CONTROL THE PROCESS. INTUITIVE SURGICAL HAS ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE 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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH PROCEDURE DATE OF (B)(6) 2013. THE SYSTEM LOGS REVEALED THAT AN ERROR 100 OCCURRED 56 MINUTES INTO THE SURGICAL PROCEDURE. THE ERROR 100 SIGNIFIED THAT THE SETUP JOINT 1 (SUJ1) ON THE PATIENT SIDE MANIPULATOR 1 (PSM1, ARM 1) WAS MOVED OR BUMPED. IT IS UNCLEAR IF THE ERROR 100 IS ASSOCIATED WITH THE REPORTED EVENT OF PSM1 MOVING INADVERTENTLY AND CONTRIBUTING TO THE PATIENT'S INJURY. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BOWEL INJURY DURING A DA VINCI SI PROSTATECTOMY PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY." } ], "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": "06/18/2013" } ] }