{ "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": "2955842-2020-10624", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200702", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20200608", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20200702", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200206", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "687250", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200702", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "M90200206", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200706", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874111048", "udi_public": "(01)00886874111048(17)220228(10)M90200206", "openfda": { "registration_number": [ "2955842" ], "fei_number": [ "3008615487" ], "device_name": "System, Surgical, Computer Controlled Instrument", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/07/2020;06/08/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "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": "20200702", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200608", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10222626", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200608", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "318961371", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "67, 4315 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT OF \"THE ENTIRE TIP COVER CAME OFF THE FORCEPS AND FELL INTO THE BODY DURING THE 3RD TO 4TH REMOVAL\". THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED ON AN IN-HOUSE MCS INSTRUMENT WITHOUT ANY ISSUE USING AN INSTALLATION TOOL. THE MCS TIP COVER ACCESSORY WAS NOT LOOSE, NOR DID IT MOVE WHILE ATTACHED ON THE TUBE EXTENSION OF THE MCS. THE MCS INSTRUMENT WAS DRIVEN AND NO INTERFERENCE OR ISSUES OCCURRED. THE MCS TIP COVER ACCESSORY DID NOT FALL OFF OR SLIDE UP AND DOWN DURING TESTING. ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER: THE MCS TIP COVER ACCESSORY WAS FOUND TO HAVE SMALL GOUGE MARKS AND TEARS ON THE BODY. GOUGE MARKS AND TEARS WERE NOT AXIALLY ALIGNED WITH THE MCS TIP COVER ACCESSORY AND MEASURED FROM 0.07\" TO 0.16\". NO MATERIAL WAS MISSING. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. THE KNOWN COMMON CAUSE OF THIS FAILURE IS MISHANDLING/MISUSE. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT REMAINS REPORTABLE BECAUSE DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE MCS TIP COVER ACCESSORY CAME OFF AND FELL INSIDE THE PATIENT. ALLEGEDLY, THE MCS INSTRUMENT WAS BEING INSERTED AND REMOVED REPEATEDLY. THE ORANGE PART AT THE TIP OF THE INSTRUMENT WAS GRADUALLY SHOWN BEFORE THE MCS TIP COVER ACCESSORY CAME OFF DURING THE 3RD TO 4TH REMOVAL. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE; HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. FAILURE ANALYSIS OF THE RETURNED MCS TIP COVER ACCESSORY WAS NOT ABLE TO REPLICATE THE REPORTED COMPLAINT. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO FALL OFF OF THE MCS INSTRUMENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR." }, { "mdr_text_key": "336070554", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336070575", "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." }, { "mdr_text_key": "232759925", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE MCS TIP COVER ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: FROM THE PHOTO, SCRATCHES WERE PRESENT ON THE TIP COVER, WHICH MOST LIKELY CAUSED BY COLLISIONS WITH ANOTHER INSTRUMENT. HOWEVER, THE REVIEWER DID NOT BELIEVE THAT THIS SORT OF DAMAGE WOULD CAUSE THE TIP COVER TO NECESSARILY FALL OFF. A CAUSE COULD NOT BE FULLY DETERMINED WITHOUT A FULL INVESTIGATION OF THE MCS TIP COVER ACCESSORY. IN ADDITION, A SMALL PUNCTURE ON THE GRAY SILICONE AREA OF THE MCS TIP COVER ACCESSORY COULD BE SEEN, HOWEVER THERE WERE NOT ANY VISIBLE SIGNS OF THERMAL DAMAGE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THE DECISION TREE WAS EXECUTED TO INDICATE THAT THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE MCS TIP COVER ACCESSORY CAME OFF AND FELL INSIDE THE PATIENT. ALLEGEDLY, THE MCS INSTRUMENT WAS BEING INSERTED AND REMOVED REPEATEDLY. THE ORANGE PART AT THE TIP OF THE INSTRUMENT WAS GRADUALLY SHOWN BEFORE THE MCS TIP COVER ACCESSORY CAME OFF DURING THE 3RD TO 4TH REMOVAL. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE; HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO FALL OFF OF THE MCS INSTRUMENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR." }, { "mdr_text_key": "232759926", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF AND FELL INSIDE THE PATIENT. ALLEGEDLY, THE MCS INSTRUMENT WAS BEING INSERTED AND REMOVED REPEATEDLY. THE ORANGE PART AT THE TIP OF THE INSTRUMENT WAS GRADUALLY SHOWN BEFORE THE TIP COVER CAME OFF DURING THE 3RD TO 4TH REMOVAL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE AND/OR DOCTOR INSPECTED THE INSTRUMENT AND TIP COVER PRIOR TO USE. NO DAMAGE OR ANY ABNORMALITY WAS OBSERVED. AFTER THE CUSTOMER USED THE MCS INSTRUMENT TO CUT TISSUE, THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT WHEN THE INSTRUMENT WAS BEING EXCHANGED OUT FOR A LARGE NEEDLE DRIVER. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT. THE MCS INSTRUMENT COLLIDED WITH THE THIRD ARM; HOWEVER, THE MCS TIP COVER ACCESSORY WAS NOT HIT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED UPON REMOVAL. AFTER 1 HOUR FROM THE START OF THE SURGERY, THE SURGICAL STAFF NOTICED THE TIP COVER WAS GETTING LOWER TOWARD THE DISTAL PART OF THE INSTRUMENT, IN WHICH THE ORANGE PART WAS VISIBLE. THE INSTRUMENT/ACCESSORY WAS IN USE FOR 2 HOURS AND 10 MINUTES. THE CUSTOMER USED A PROGRASP FORCEPS TO RETRIEVE THE MCS TIP COVER ACCESSORY THROUGH AN ASSISTANT PORT. THE PROCEDURE WAS COMPLETED WITH A LARGE NEEDLE DRIVER. THE CUSTOMER USED THE INSTALLATION TOOL TO INSTALL THE MCS TIP COVER ACCESSORY, WHICH APPEARED TO BE PROPERLY INSTALLED AT THE BEGINNING OF THE SURGICAL PROCEDURE. AFTER REMOVING THE MCS INSTRUMENT FROM THE ARM AND REINSTALLING, THE ORANGE SURFACE WAS VISIBLE. NO ELECTROLUBE WAS USED AND THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE MCS INSTRUMENT IS NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED, BUT THE SITE WAS UNWILLING TO PROVIDE THE INFORMATION DUE TO THE HOSPITAL¿S PRIVACY POLICY." } ], "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": "08/02/2020;05/24/2023" } ] }