{ "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": "2955842-2013-02866", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130801", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130626", "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", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130802", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "359724", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130801", "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": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20130725", "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": [ "Device Displays Incorrect Message" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20130801", "sequence_number_treatment": [ "DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Information" ] } ], "distributor_city": "", "date_report": "20130702", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3260270", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "10982823", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE VESSEL SEALER INSTRUMENT WAS RETURNED TO ISI AND EVALUATED. ENGINEERING WAS UNABLE TO INSTALL THE INSTRUMENT THROUGH AN 8MM CANNULA BASED ON THE CONDITION THE DEVICE WAS RECEIVED. ENGINEERING EVALUATED THE INSTRUMENT BY INSTALLING THE DEVICE IN A LARGER DIAMETER STAPLER CANNULA. THE INSTRUMENT BLADE WAS NOT FOUND TO BE DISLODGED. ENGINEERING INDICATED THAT THE INSTRUMENT WAS ABLE TO CUT AND SEAL PROPERLY. HOWEVER, ACCORDING TO ENGINEERING, BIO-DEBRIS WAS FOUND IN BOTH BLADE TRACKS. ENGINEERING INDICATED THAT EXCESSIVE BIO-DEBRIS MAY HAVE CONTRIBUTED TO BLADE JAMS. ENGINEERING ALSO FOUND THE INSTRUMENT'S PITCH/YAW WRIST DISC DISLODGED FROM THE MIDDLE WRIST DISC. THE RANGE OF MOTION OF THE INSTRUMENT WAS LIMITED DUE TO THE DISLODGEMENT. ENGINEERING CONCLUDED THAT THE DISLODGEMENT WAS LIKELY DUE TO MISHANDLING/MISUSE." }, { "mdr_text_key": "18855066", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE SURGEON ENCOUNTERED A RECOVERABLE FAULT WHILE USING THE VESSEL SEALER INSTRUMENT. THE INITIAL REPORTER (ROBOTICS COORDINATOR) OF THIS COMPLAINT CONTACTED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. HOWEVER, DURING THE CALL, THE ROBOTICS COORDINATOR DID NOT HAVE TIME TO TROUBLESHOOT. THE ROBOTICS COORDINATOR INDICATED THAT THE SURGEON CHOSE TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO TRADITIONAL LAPAROSCOPIC TECHNIQUES. INITIALLY, NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND FOUND AN ERROR 32001 RELATED TO THE VESSEL SEALER INSTRUMENT. AN ERROR 32001 INDICATES THAT THE VESSEL SEAL INSTRUMENT CUTTING BLADE CANNOT BE RETRACTED AND MAY BE EXPOSED." }, { "mdr_text_key": "19210377", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REPAIRED THE DA VINCI SI SURGICAL SYSTEM BY REPLACING THE INSTRUMENT CONTROL BOX (ICB). THE FSE TESTED AND VERIFIED THE SYSTEM TO MANUFACTURER SPECIFICATIONS WHILE USING A VESSEL SEALER TRAINING INSTRUMENT. ON (B)(6) 2013, ISI CONTACTED THE ROBOTICS COORDINATOR FOR FOLLOW-UP INFORMATION. THE ROBOTICS COORDINATOR INDICATED THAT THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED VIA TRADITIONAL LAPAROSCOPIC TECHNIQUES WITH NO REPORT OF INJURY. HOWEVER, CONTRARY TO THE INITIAL REPORT THE ROBOTICS COORDINATOR ALSO INDICATED THAT THERE WAS A POST OPERATIVE COMPLICATION WHICH REQUIRED THE PATIENT TO RETURN TO SURGERY. THE ROBOTICS COORDINATOR INDICATED THAT THE CONVERSION FROM THE DA VINCI PROCEDURE TO LAPAROSCOPIC DURING THE (B)(6) 2013 CASE WAS DIRECTLY DUE TO THE ISSUE OF THE FAULT EXPERIENCED WITH THE VESSEL SEALER INSTRUMENT. ON (B)(6) 2013, ISI CONTACTED THE ROBOTICS COORDINATOR TO REQUEST FURTHER INFORMATION, AT WHICH TIME THE ROBOTICS COORDINATOR INDICATED THAT SHE WAS NOT PRESENT IN THE OPERATING ROOM (OR) WHEN THE SURGICAL PROCEDURE WAS STARTING. WHEN ROBOTICS COORDINATOR ARRIVED IN THE OR, SHE INDICATED THAT THE SURGEON WAS ATTEMPTING TO RELEASE TISSUE THAT WAS BEING HELD BY THE VESSEL SEALER INSTRUMENT AND FOR AN UNKNOWN REASON THE SURGEON WAS REPORTEDLY UNABLE TO RELEASE THE GRIPS ON THE INSTRUMENT. THE SURGICAL ASSISTANT AT THE PATIENT SIDE CART (PSC) WAS UNABLE TO TROUBLESHOOT THE REPORTED PROBLEM WITH THE INSTRUMENT, HOWEVER, THE ROBOTICS COORDINATOR STATED THAT THE REPORTED ISSUE WAS RESOLVED AFTER A FAULT OVERRIDE WAS PERFORMED. AT AN UNSPECIFIED TIME AFTER THE SURGICAL PROCEDURE WAS COMPLETED VIA TRADITIONAL LAPAROSCOPIC TECHNIQUES, THE ROBOTICS COORDINATOR INDICATED THAT THE PATIENT WAS BROUGHT BACK TO THE OR DUE TO EXPERIENCING UNSPECIFIED POST-OPERATIVE COMPLICATIONS. THE ROBOTICS COORDINATOR WAS UNABLE TO PROVIDE DETAILS OF WHAT POST-OPERATIVE COMPLICATIONS THE PATIENT SUSTAINED. IN ADDITION, SHE DID NOT KNOW IF THE SURGICAL COMPLICATIONS WERE RELATED TO THE DA VINCI SI SURGICAL SYSTEM OR THE TRADITIONAL LAPAROSCOPIC SURGERY. THE ICB WAS RETURNED TO ISI AND EVALUATED. ENGINEERING EVALUATION WAS UNABLE TO REPLICATE THE REPORTED ISSUE BY INSTALLING THE ICB ON AN IN-HOUSE PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM AND EXERCISING A VESSEL SEALING INSTRUMENT MULTIPLE TIMES. THE VESSEL SEALING INSTRUMENT CAUTERIZED, SEALED, AND CUT WITHOUT ANY ERRORS. THE VESSEL SEALER INSTRUMENT INVOLVED WITH THIS COMPLAINT HAS BEEN REQUESTED TO BE RETURNED TO ISI FOR EVALUATION. HOWEVER, AT THIS TIME THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE INITIAL REPORTER INDICATED THAT THE PATIENT SUSTAINED AN UNSPECIFIED POST-OPERATIVE COMPLICATION AND WAS BROUGHT BACK TO THE OR. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S REPORTED INJURY. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE 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": "08/05/2013" } ] }