{ "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": "I", "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": "2955842-2020-11115", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201023", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20200925", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GB", "manufacturer_contact_area_code": "", "date_added": "20201023", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1190694", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201023", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "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": "480440-05", "catalog_number": "480440", "lot_number": "T90200116 0257", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)220131(10)T90200116", "openfda": { "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": "11/16/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20201023", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20200925", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10731113", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200925", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "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": "239999093", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) REQUESTED FOR THE SYNCHROSEAL INSTRUMENT TO BE RETURNED FOR EVALUATION, BUT THE CUSTOMER DISCARDED THE SYNCHROSEAL INSTRUMENT AND, THEREFORE, WILL NOT BE RETURNING THE SYNCHROSEAL INSTRUMENT FOR ISI'S EVALUATION. IMAGE/VIDEO REVIEW: AN IMAGE OF THE DEVICE WAS PROVIDED AFTER THE REPORTED ISSUE OCCURRED. THE IMAGE DEPICTED THE DISTAL END OF THE INSTRUMENT AND THE PIVOT PIN WASHER WAS OBSERVED TO BE MISSING AS REPORTED. NO OTHER DAMAGE WAS VISIBLE IN THE PHOTO AND THERE WAS NOTHING IN THE PHOTO THAT WOULD EXPLAIN THIS REPORTED EVENT'S OCCURRENCE. THE REPORTED \"SPLIT\" OF THE JAW COVER WAS NOT VISIBLE IN THE PHOTO PROVIDED, INDICATING THAT IT IS LIKELY ON THE SIDE OF THE INSTRUMENT NOT DEPICTED IN THE IMAGE. IT WAS REPORTED THAT THE PROCEDURE WAS RECORDED ON VIDEO; HOWEVER, THE USER FACILITY HAS NOT RELEASED THE VIDEO FOR ISI'S REVIEW. IF ISI RECEIVES VIDEO FOOTAGE FROM THE PROCEDURE, A SUPPLEMENTAL MDR WILL BE SUBMITTED WITH ADDITIONAL INFORMATION ONCE THE REVIEW HAS BEEN COMPLETED. INSTRUMENT LOG INVESTIGATION: A REVIEW OF THE INSTRUMENT LOGS FOR THE SYNCHROSEAL INSTRUMENT (PART# 480440-05/LOT-SEQUENCE# T90200116-0257) ASSOCIATED WITH THIS EVENT WAS PERFORMED. PER THIS REVIEW OF THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2020 ON SYSTEM (B)(4) AS REPORTED, FOR ITS ONLY ALLOTTED USAGE. THE SITE'S COMPLAINT HISTORY WAS REVIEWED AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED TO BE RELATED TO THIS PRODUCT/EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE SYNCHROSEAL INSTRUMENT¿S PIVOT PIN WASHER FELL OFF THE INSTRUMENT DURING THE PROCEDURE AND WAS RETAINED WITHIN THE PATIENT. UNINTENDED FRAGMENTS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE WASHER TO FALL INTO THE PATIENT." }, { "mdr_text_key": "239999097", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL EXCISION SURGICAL PROCEDURE, A SYNCHROSEAL INSTRUMENT PIVOT PIN WASHER DETACHED FROM THE INSTRUMENT AND FELL INSIDE THE PATIENT. IT WAS REPORTED THAT THE WASHER WAS RETAINED WITHIN THE PATIENT. IT WAS ALSO NOTED THAT THE SYNCHROSEAL INSTRUMENT¿S JAW COVER HAD A SPLIT/TEAR. 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 PIVOT PIN WASHER WAS PRESENT DURING INSTRUMENT INSPECTION AND AT THE BEGINNING OF THE PROCEDURE. THE REPORTED ISSUE OCCURRED DURING USE, BUT IT IS UNKNOWN WHAT EXACT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE REPORTED EVENT. THE SURGEON BELIEVED THAT THE CAUSE OF THE REPORTED ISSUE COULD HAVE BEEN A POTENTIAL CLASH WITH ANOTHER INSTRUMENT, HOWEVER THIS WAS NOT CONFIRMED TO BE THE CAUSE OF THE REPORTED EVENT. IT WAS ALSO INDICATED THAT IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT OR OTHER HARD MATERIAL AT THE TIME OF THE REPORTED EVENT. THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR OVER FOUR HOURS WHEN THE REPORTED USE OCCURRED. THE PIVOT PIN WASHER DID NOT APPEAR TO HAVE ANY CRACKS, DAMAGE, OR ABNORMALITIES. THE PIVOT PIN THAT HOLDS THE WASHER DID NOT APPEAR TO BE LOOSE OR DISLODGED. REGARDING THE REPORTED ¿SPLIT¿ OF THE JAW COVER, IT WAS REPORTED THAT NO FRAGMENTS FELL INSIDE THE PATIENT AS A RESULT OF THE ¿SPLIT.¿ ADDITIONALLY, THE ¿SPLIT¿ DID NOT RESULT IN ANY FUNCTIONAL ISSUES WITH THE DEVICE. IT IS NOT BELIEVED THAT THE SPLIT OF THE JAW COVER WAS RELATED TO THE PIVOT PIN WASHER DETACHING FROM THE INSTRUMENT. THE PROCEDURE WAS RECORDED, BUT AT THIS TIME, IT IS UNKNOWN IF ISI MAY OBTAIN A COPY OF IT FOR EVALUATION. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE CUSTOMER. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE DA VINCI SURGICAL SYSTEM. ADDITIONALLY, IT WAS NOTED THAT THERE WAS NO INJURY OR ADVERSE OUTCOME FOR THE PATIENT. THE PROCEDURE WAS DELAYED FOR 15 MINUTES AS A RESULT OF THIS REPORTED EVENT¿S OCCURRENCE. PATIENT DEMOGRAPHIC INFORMATION IS UNKNOWN AT THIS TIME. ISI FOLLOWED-UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: VIDEO MAY BE AVAILABLE FOR REVIEW. THE SURGEON IS REQUESTING FOR PATIENT CONSENT BEFORE SHARING THE VIDEO. HOWEVER, IT IS UNKNOWN IF THE PATIENT WILL CONSENT TO RELEASING THE VIDEO AT THIS TIME. THE SURGEON REPORTED THAT THE PATIENT IS HOME AND WELL AND THERE HAVE BEEN NO POST-OPERATIVE COMPLICATIONS. NO ADDITIONAL TESTS OR SURGERIES HAVE BEEN PERFORMED." }, { "mdr_text_key": "315393045", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN FIELDS G4, G7, H2, H6, AND H10/H11. INTUITIVE SURGICAL, INC. (ISI) RECEIVED VIDEO FOOTAGE FROM THE SURGEON AND PERFORMED A REVIEW OF THE PROCEDURE TO FURTHER INVESTIGATE THE REPORTED EVENT. AN ISI MANAGING ENGINEER REVIEWED THE VIDEO PROVIDED BY THE SURGEON AND NOTED THAT THE PIVOT PIN WASHER BECAME DISLODGED DURING A COLLISION WITH A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. IT WAS NOTED THAT THERE WERE SEVERAL COLLISIONS/SLIDING MOTIONS BETWEEN THE SYNCHROSEAL INSTRUMENT AND THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT THROUGHOUT THE PROCEDURE. FROM THE VIDEO REVIEW, IT APPEARED THAT DURING THE COLLISION, THE PIVOT PIN WASHER BECAME CAUGHT AGAINST A FEATURE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND SUBSEQUENTLY DISLODGED FROM THE INSTRUMENT AND FELL INTO THE PATIENT. THE PIVOT PIN WASHER WAS OBSERVED TO BE REMOVED FROM VIEW DURING THE VIDEO REVIEW. AN ISI CLINICAL DEVELOPMENT ENGINEER ALSO REVIEWED THE VIDEO PROVIDED BY THE SURGEON. IT WAS NOTED THAT WHILE THE SURGEON WAS DISSECTING OUT THE POSTERIOR SIDE OF THE RECTUM, THE SYNCHROSEAL INSTRUMENT HAD A PUSHING/SNAPPING LIKE COLLISION ACROSS THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT AT WHICH POINT THE PIVOT PIN WASHER DISLODGED FROM THE SYNCHROSEAL INSTRUMENT. IT WAS NOTED THAT THROUGHOUT THE PROCEDURE, THERE WERE MULTIPLE SIMILAR COLLISIONS WITH THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND SUCTION IRRIGATOR AND THAT THE SURGEON WAS WORKING IN A NARROW SPACE. THE COLLISIONS WERE NOTED TO LIKELY HAVE CONTRIBUTED TO THE OBSERVED TEAR IN THE SYNCHROSEAL INSTRUMENT¿S JAW COVER AS WELL. APPROXIMATELY FIVE MINUTES AFTER THE PIVOT PIN WASHER WAS OBSERVED TO HAVE FALLEN INTO THE PATIENT, IT WAS OBSERVED TO HAVE BEEN RETRIEVED AND TAKEN FROM VIEW WITH A LAPAROSCOPIC GRASPER INSTRUMENT. ISI FOLLOWED-UP WITH THE INITIAL REPORTER AND IT WAS CONFIRMED THAT THE PIVOT PIN WASHER WAS NOT RETRIEVED. THE PIVOT PIN WASHER BECAME CAUGHT WITHIN THE ASSISTANT PORT UPON REMOVAL AND FELL BACK INTO THE PATIENT'S ABDOMEN. FOLLOWING FURTHER LAPAROSCOPIC INSPECTION, THE PIVOT PIN WASHER COULD NOT BE FOUND." }, { "mdr_text_key": "315393046", "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": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/07/2020" } ] }