{ "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": "2955842-2021-10464", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210430", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210406", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHARMACIST", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20210430", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200910", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "653310", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210430", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "M90200911", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210514", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)M90200911", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation", "Material Split, Cut or Torn", "Material Separation", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/17/2021;04/06/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20210430", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "43 YR", "patient_sex": "Female", "patient_weight": "160 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210406", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11751297", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210406", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "324369725", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "324369726", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D02: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION DID NOT REPLICATE NOR CONFIRM THE REPORTED COMPLAINT OF ¿SHEATH HAS BECOME DETACHED FROM THE FORCEPS.¿ THE MCS TIP COVER ACCESSORY WAS INSTALLED ON AN INSTRUMENT ON AN IN-HOUSE SYSTEM. THE MCS TIP COVER ACCESSORY REMAINED ON THE INSTRUMENT THROUGHOUT THE ENTIRE TEST. THE INSTRUMENT WAS INSTALLED AND REMOVED FROM THE SYSTEM SEVERAL TIMES WITH NO ISSUES. ADDITIONALLY, THE MCS TIP COVER ACCESSORY WAS FOUND TO HAVE TEARING AT THE MOUTH ON THE DISTAL END. TEARS WERE AXIALLY ALIGNED WITH THE MCS TIP COVER ACCESSORY AND MEASURED FROM 0.023¿ TO 0.121¿ IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. TEARS AT THE MOUTH ARE MOST COMMONLY CAUSED BY REPEATED THERMAL AND MECHANICAL STRESSES. THE ROOT CAUSE OF THE TEARS IS ATTRIBUTED TO A COMPONENT FAILURE." }, { "mdr_text_key": "268075533", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT RECEIVED THE MCS TIP COVER ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED A COMPLAINT FOR THE ADDITIONAL MCS TIP COVER ACCESSORY THAT WAS FOUND TO BE DAMAGED DURING THIS PROCEDURE. PLEASE REFER TO THE REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE OTHER MCS TIP COVER ACCESSORY. THE MCS TIP COVER ACCESSORY, WHEN USED AS INTENDED, PROVIDES INSULATION OVER A SECTION OF THE ENDOWRIST MCS INSTRUMENT SO THAT RADIO FREQUENCY (RF) ENERGY IS ONLY AVAILABLE AT THE INSTRUMENT SCISSOR TIPS. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE MCS TIP COVER ACCESSORY REPORTEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. UPON RETRIEVAL, THE MCS TIP COVER ACCESSORY WAS NOTED TO HAVE A CRACK AND THERE WAS NO EVIDENCE OR CLAIM OF MISHANDLING/MISUSE. ALTHOUGH THERE WAS NO PATIENT INJURY REPORTED, THESE FAILURE MODES COULD RESULT IN AN ADVERSE EVENT IF THEY WERE TO RECUR." }, { "mdr_text_key": "268075534", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY BECAME DETACHED FROM THE MCS INSTRUMENT AND FELL INTO THE PATIENT. IT WAS ALSO NOTED THAT THE MCS TIP COVER ACCESSORY WAS CRACKED. A SECOND MCS TIP COVER ACCESSORY WAS ALSO NOTED TO BE CRACKED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 28-APR-2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A TOTAL HYSTERECTOMY WITH BILATERAL ADNEXECTOMY. THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DEFECT WAS DETECTED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITH A SHEATH PROVIDED IN THE PACKAGE TO REMOVE IT. THE SURGEON WAS PERFORMING DISSECTION WHEN THE MCS TIP COVER ACCESSORY FELL. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE MCS INSTRUMENT. THE CUSTOMER IS UNSURE IF THE MCS INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THE MCS INSTRUMENT WAS NOT STRAIGHTENED UPON REMOVED. AFTER THE MCS TIP COVER ACCESSORY FELL, A CRACK WAS NOTED. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE USED FOR 5 HOURS. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED. NO PART OF THE ORANGE SURFACE WAS VISIBLE AND THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. ELECTROLUBE/LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO TIP COVER INSTALLATION. THE MCS TIP COVER ACCESSORY WAS CHANGED 3 TIMES AS THERE WAS A CRACK ON 2 MCS TIP COVER ACCESSORIES. IT IS UNKNOWN IF THE MCS INSTRUMENT WILL BE RETURNED TO ISI FOR EVALUATION. NO IMAGE OR VIDEO IS AVAILABLE FOR ISI REVIEW. THE PROCEDURE WAS NOT PROLONGED DUE TO THE ISSUE." }, { "mdr_text_key": "337076419", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1 : B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." }, { "mdr_text_key": "337076420", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/12/2021;05/24/2023" } ] }