{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2024-22533", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20241206", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20241107", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20241206", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240606", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2245304", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241206", "brand_name": "DA VINCI", "generic_name": "SEAL", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "470500-13", "catalog_number": "470500", "lot_number": "K14240606", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "10886874116408", "udi_public": "(01)10886874116408(10)K14240606", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20241206", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "36 YR", "patient_sex": "Male", "patient_weight": "86 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20241107", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20860448", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241107", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "358441314", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A RETURN MATERIAL AUTHORIZATION (RMA) WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THAT THE ACCESSORY WAS SENT TO PATHOLOGY. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE." }, { "mdr_text_key": "358441315", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, A PIECE OF THE CANNULA BROKE INTO THE PATIENT. A GREY RUBBERY PART WAS RETRIEVED IMMEDIATELY. THE PART AND DETACHED PIECE COULD NOT BE RETURNED AS IT WAS SENT TO PATHOLOGY. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE NOTED. THE SURGEON BELIEVED INSTRUMENT INTRODUCTION WAS THE CAUSE OF THE FRAGMENT FELLING INTO THE PATIENT AND THE CAUSE OF THE ACCESSORY BREAKING WAS THE INTRODUCTION OF THE TIP OF THE SCISSORS. THE ACCESSORY WAS IN USE FOR ABOUT 45 MINUTES WHEN THE BREAKAGE OCCURRED. NO ISSUES WERE NOTED WITH THE FUNCTIONALITY OF THE ACCESSORY DURING THE SURGICAL PROCEDURE; MULTIPLE INSTRUMENTS PASSED THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE TO THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA DURING THE PROCEDURE. UPON THE FINAL REMOVAL, THE WRIST OF THE INSTRUMENT WAS STRAIGHT. THERE WAS ALSO NO RESISTANCE UPON REMOVING THE INSTRUMENT THROUGH THE CANNULA. THE DAMAGE TO THE CANNULA WAS NOTED AFTER THE EVENT OCCURRED. NO ADDITIONAL DAMAGE WAS NOTED TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE FRAGMENT WAS RETRIEVED AND REMOVED IMMEDIATELY VIA BOWEL GRASPER, THE SURGEON SCANNED THE ENTIRE ABDOMINAL CAVITY AND NOTED NO ADDITIONAL FRAGMENTS. THEN, THE SURGICAL TEAM INSPECTED ALL ROBOTIC TROCARS AND NOTED A TINY PIECE WAS MISSING. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE MISSING PORTION OF THE TROCAR CORRELATED TO THE EXACT SHAPE AND SIZE OF THE FOREIGN BODY. THE SURGEON DEEMED NO FURTHER INTERVENTION NECESSARY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATION RELATED TO RETAINING A FOREIGN OBJECT. THERE ARE NO IMAGES ON THE DEVICE OR VIDEO RECORDINGS OF THE PROCEDURE AVAILABLE FOR ISI REVIEW." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }