{ "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": "2955842-2013-05243", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20131118", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131018", "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": "20131118", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "595315", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131118", "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": "20131101", "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": [ "Break", "Human-Device Interface Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20131118", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "38 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20131018", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3473388", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131018", "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": "11337327", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, THE USER FACILITY REPORTED DAMAGE TO 4 DIFFERENT INSTRUMENTS THAT WERE USED DURING THIS REPORTED EVENT. REVIEW OF THE SYSTEM LOG CONFIRMED THAT THE REPORTED INSTRUMENTS WERE 4 OF THE 5 INSTRUMENTS THAT WERE USED DURING THE REPORTED DA VINCI PROCEDURE. THE 4 INSTRUMENTS INVOLVED WITH THE REPORTED EVENT HAVE BEEN RETURNED TO ISI AND EVALUATED. FAILURE ANALYSIS INVESTIGATIONS NOTED THE FOLLOWING FINDINGS: INSTRUMENT 1: MONOPOLAR CURVED SCISSORS (MCS) (PART 420179, LOT M14130619-891): FINDINGS: TUBE EXTENSION WAS FOUND BROKEN AND WAS MISSING A PIECE AT THE DISTAL END. INSTRUMENT 2: MONOPOLAR CURVED SCISSORS (PART 420179, LOT M14130619-047): FINDINGS: TUBE EXTENSION WAS FOUND BROKEN AND WAS MISSING A PIECE AT THE DISTAL END. INSTRUMENT 3: PERMANENT CAUTERY SPATULA (PART 420184-06 , LOT M10120523-783): FINDINGS: BROKEN CERAMIC SLEEVE, HEAVY BIODEBRIS AND BLACK BURNT OR CHAR MARKS RESIDING AROUND THE SPATULA, AND AN UNEVEN PIECE OF THE CERAMIC SLEEVE WAS MISSING, EXPOSING THE SHAFT OF THE SPATULA. THERE WAS ALSO A DERAILED YAW CABLE AT THE INSTRUMENT'S WRIST AND BOTH PITCH CABLES WERE BROKEN. PLEASE REFERENCE MDR WITH PATIENT IDENTIFIER (B)(6). INSTRUMENT 4: MARYLAND BIPOLAR FORCEPS (PART 420172-07 , LOT M10130819): FINDINGS: BROKEN PITCH CABLE AT THE PROXIMAL CLEVIS HUB. PLEASE REFERENCE MDR WITH PATIENT IDENTIFIER 700108065. INVESTIGATION NOTED THAT THE DAMAGE FOUND ON THE 2 MCS INSTRUMENTS AND PERMANENT CAUTERY SPATULA ARE LIKELY DUE TO MISUSE OR MISHANDLING. THE INSTRUMENTS & ACCESSORIES INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. BASED ON THE PROVIDED INFORMATION, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SURGICAL PROCEDURE AND THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE." }, { "mdr_text_key": "4028722", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, THE USER FACILITY CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) DURING A DA VINCI MYOMECTOMY PROCEDURE AND REQUESTED HER TO COME IN BECAUSE MULTIPLE INSTRUMENTS KEPT BREAKING. WHEN THE CSR ARRIVED, SHE NOTED THAT THE PORT PLACEMENT WAS INCORRECT FOR THE TYPE OF SURGICAL PROCEDURE AND THE VISION WAS OBSCURED, NOT ALLOWING THE INSTRUMENT TIPS TO BE VIEWED. THE CSR STATED THAT THE SURGEON WAS RESISTANT TO HER RECOMMENDATIONS BUT FINALLY AGREED TO MOVE THE CAMERA PORT FOR A BETTER VIEW OF THE INSTRUMENTS. ACCORDING TO THE CSR, THE SURGEON REPEATEDLY OVER ROTATED THE MASTER TOOL MANIPULATOR (MTM) AND KEPT LOSING VIEW OF THE INSTRUMENT'S TIPS. 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 SIDE CONSOLE. THE INSTRUMENTS WERE BEING PUSHED AGAINST THE MYOMA WITH ENOUGH FORCE THAT IT WAS CAUSING THE INSTRUMENTS TO BREAK. THE CSR STATED SHE WITNESSED THE INSTRUMENT CABLES BREAKING ON A MARYLAND BIPOLAR INSTRUMENT. THE CSR OBSERVED THAT THE VIEW OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIPS WAS LOST AND THE SURGEON WAS ENGAGING THE MCS INSTRUMENT AS IF HE WAS CUTTING TISSUE AND THE PATIENT SUSTAINED A POSSIBLE ARTERY NICK IN THE RIGHT PELVIC SIDE WALL. THE DA VINCI PROCEDURE WAS THEN CONVERTED TO AN OPEN SURGICAL PROCEDURE. THE CSR WAS UNABLE TO OBTAIN INFORMATION REGARDING THE BROKEN INSTRUMENTS THAT WERE USED PRIOR TO HER ARRIVAL. THE FOLLOWING DAY, AN ISI FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND DID NOT FIND ANY ISSUES WITH THE DA VINCI SYSTEM AND VERIFIED THAT THE DA VINCI SYSTEM WAS READY FOR USE. ON (B)(6) 2013, THE USER FACILITY REPORTED DAMAGE TO 4 DIFFERENT INSTRUMENTS THAT WERE USED DURING THIS REPORTED EVENT. ON (B)(6) 2013, ISI SPOKE WITH THE CSR. THE CSR STATED THAT THE PATIENT'S RIGHT EXTERNAL ILIAC VEIN WAS TRANSECTED. SHE WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION REGARDING THE INJURY AND DETAILS REGARDING THE REASON WHY THE SURGEON CONVERTED THE PROCEDURE TO AN OPEN SURGICAL PROCEDURE. SHE ALSO STATED THAT THE SURGEON HAD NOT PERFORMED ANY DA VINCI SURGERIES BETWEEN (B)(6) 2012 AND (B)(6) 2013. THE CSR REPORTED THAT SHE HAD OFFERED THE SURGEON SUPPLEMENTAL TRAINING SESSIONS PRIOR TO THE PROCEDURE BUT THEY WERE NOT UNDERTAKEN. ON (B)(6) 2013, AN ISI CLINICAL CONSULTANT SPOKE WITH THE BED-SIDE ASSISTANT SURGEON TO THE DA VINCI SURGEON PERFORMING THE CASE. HE CONFIRMED THAT THE PATIENT'S RIGHT ILIAC VEIN WAS LACERATED AND THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE TO REPAIR THE INJURY. HE CONFIRMED THAT THE DA VINCI SURGEON HAD DIFFICULTY OPERATING WITH THE DA VINCI SYSTEM. HE RECALLED THERE WAS OVER ROTATION OF THE MASTER TOOL MANIPULATOR (MTM) AND SOME DEGREE OF FRUSTRATION IN KEEPING ALL INSTRUMENTATION IN VIEW. IT WAS THEN THAT INJURY OCCURRED, ALTHOUGH HIS ATTENTION AT THE EXACT MOMENT OF THE DAMAGE WAS ON A DIFFERENT PART OF THE SCREEN. HE DID NOT THINK THAT THE INJURY HAPPENED OUT OF VIEW OF THE CAMERA." } ], "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": "" } ] }