{ "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": "2955842-2015-01191", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150910", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150518", "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", "USER FACILITY" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150910", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "599316", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150910", "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": "No", "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": [ "Loose or Intermittent Connection", "Failure to Disconnect" ], "reporter_state_code": "WV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20150910", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20150518", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5069692", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150518", "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": "25483427", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE AS TO WHY 3 PLUNGER PINS ON ARM 1 BECAME UNSCREWED. THE TFS INSPECTED ARM 1 AND WAS ABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE. THE TFS IDENTIFIED THAT 3 OF 4 PLUNGER PINS ON ARM 1 WERE UNSCREWED HALFWAY. THE TFS REPAIRED ARM 1 BY TIGHTENING THE 3 PLUNGER PINS. A RECURRENCE OF THE REPORTED AND OBSERVED FAILURE MODE OF HAVING DIFFICULTY REMOVING INSTRUMENTS FROM ARM 1 IS NOT EXPECTED TO CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-EVALUATED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A SUPERFICIAL LIVER LACERATION DURING THE DA VINCI SURGICAL PROCEDURE THAT WAS CAUTERIZED BY THE SURGEON." }, { "mdr_text_key": "25483448", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY PROCEDURE, THE SURGICAL STAFF WAS HAVING DIFFICULTY REMOVING INSTRUMENTS FROM ARM 1 ON THE SURGEON SIDE CONSOLE (SSC). THE SURGICAL STAFF WOULD SQUEEZE THE RELEASE TABS ON THE INSTRUMENTS BUT WOULD HAVE DIFFICULTY UNINSTALLING THE INSTRUMENTS FROM THE ARM. EACH TIME THE ISSUE OCCURRED, THE SURGICAL STAFF WAS EVENTUALLY ABLE TO REMOVE THE INSTRUMENT FROM THE ARM. ON (B)(6) 2015, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE AND WAS ABLE TO REPLICATE THE REPORTED CUSTOMER COMPLAINT. THE TFS RESOLVED THE REPORTED ISSUE WITH ARM 1 BY SCREWING IN THREE PLUNGER PINS THAT APPEARED TO BE UNSCREWED HALF WAY. THE TFS INSPECTED AND TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. THERE WERE NO REPORTS OF A PATIENT INJURY OR ADVERSE EVENT. ON 08/13/2015, ISI RECEIVED FDA VOLUNTARY REPORT MW5042851 WITH THE FOLLOWING EVENT DESCRIPTION: ARM OF THE DAVINCI MACHINE WOULD NOT RELEASE THE INSTRUMENT. THE ASSISTANT TRIED TO REMOVE THE INSTRUMENT AND THE INSTRUMENT SHIPPED [SIC], CAUSING A SUPERFICIAL LACERATION OF THE LIVER. CAUTERY WAS USED TO STOP THE BLEEDING. I CAME BY YESTERDAY TO LOOK AT ARM 1 FOR INSTRUMENTS STICKING WHEN TRYING TO REMOVE THEM. I HAD MY INSTRUMENTS STICKING A LITTLE BIT ON ARM 1 ALSO. I FOUND THREE OF THE PLUNGER PIN HOLDERS HAD COME UNSCREWED ABOUT HALFWAY. WHICH WAS CAUSING THE INSTRUMENTS TO BE RELEASED AT AN ANGLE AND THAT WAS CAUSING THEM TO STICK WHEN BEING RELEASED. AFTER TIGHTENING DOWN THE PLUNGER PIN HOLDERS MY INSTRUMENTS CAME OUT VERY SMOOTHLY WITH NO STICKING. I'M NOT SURE IF THE PROBLEM THEY HAD ON (B)(6) WAS ENTIRELY CAUSED BY THE PLUNGER PINS BEING BACKED OUT OR A COMBINATION OF THE PINS AND MAYBE A BAD STERILE ADAPTER. ON 09/08/2015 AND 09/09/2015, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT AND OBTAINED THE FOLLOWING INFORMATION: DURING ATTEMPTS TO REMOVE AN INSTRUMENT, ARM 1 SLIPPED AND THE LACERATION TO LIVER OCCURRED. THE LIVER LACERATION WAS MINOR AND THE CAUTERIZATION WAS LIKELY PERFORMED AS A PRECAUTIONARY MEASURE TO PREVENT ADDITIONAL BLEEDING. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 25 CC. THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. THE REPORTED ISSUE WAS RESOLVED AFTER THE PLUNGER PINS WERE TIGHTENED." } ], "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": "" } ] }