{ "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": "2955842-2020-10517", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200528", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20200511", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "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": "20200528", "manufacturer_contact_f_name": "DAVID", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "559673", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200528", "brand_name": "DA VINCI XI", "generic_name": "HARMONIC ACE", "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": "480275-08", "catalog_number": "480275", "lot_number": "M90191117", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/10/2020;10/16/2020;05/15/2020", "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": "20200528", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "90 YR", "patient_sex": "Female", "patient_weight": "76 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200515", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10094833", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200515", "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": "319523863", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "319523864", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS A2, A3, A4, E4, G4, G7, H2, AND H10. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A USER FACILITY REPORT 2100090000-2020-8009 STATING THE FOLLOWING: \"WHEN USING THE ROBOTIC HARMONIC ACE SCALPEL WITH THE HARMONIC SCALPEL GENERATOR, THE BLADE SHEARED OFF AND HAD TO BE RETRIEVED FROM THE PATIENT DURING THE PROCEDURE USING LAPAROSCOPIC GRASPER. THE HARMONIC SCALPEL HANDPIECE SETTINGS WERE COAGULATION THREE AS LOW, AND FIVE AS HIGH SETTING. THE INSTRUMENT WAS IN USE FOR THE PROCEDURE FOR APPROXIMATELY TWO HOURS BEFORE IT BROKE. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE AND THE WRIST WAS STRAIGHTENED PRIOR TO REMOVAL. IT WAS ALSO STRAIGHTENED UPON FINAL REMOVAL. NO RESISTANCE WAS NOTED ON REMOVAL. NOTHING WAS NOTED AS OUT OF THE ORDINARY FOR THIS PROCEDURE. ALL FRAGMENTS WERE RETRIEVED, AND NO HARM WAS NOTED TO THE PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : ROBOTIC WHIPPLE SURGERY FOR PANCREATIC CANCER (HARMONIC SCALPEL WAS USED FOR THE TRANSECTION ON THE RIGHT GASTRIC ARTERY AND NECK OF THE PANCREAS) WHAT PROBLEM DID THE USER HAVE CHECK ALL THAT APPLY: DEVICE FAILED ( BROKE, COULDN'T GET IT TO WORK.)\" THE USER FACILITY REPORT ALSO NOTED THAT THE PRODUCT WAS AVAILABLE FOR EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED BY ISI." }, { "mdr_text_key": "335845817", "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": "335845818", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "321676349", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PLEASE SEE FIELD G4, H2, H6 (METHOD CODE) AND H10/H11 FOR ADDITIONAL INFORMATION. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE INITIAL REPORTER OF THE USER FACILITY MEDWATCH (UFMW) REPORTS AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ALL EVENTS REPORTED IN UFMW REPORTS 2100090000-2020-8008 (MFR REPORT NUMBERS 2955842-2020-10519, 2955842-2020-10520, AND 2955842-2020-10518), 2100090000-2020-8009 (MFR REPORT NUMBER ), AND 2100090000-2020-8011 (MFR REPORT NUMBER 2955842-2020-10916) OCCURRED WITH THE SAME SURGEON. IT WAS INDICATED THAT THIS THE SITE IS ¿CHECKING WITH ALL USERS TO SEE IF [THERE IS] ANY FEEDBACK.¿ NO OTHER CONTINUITIES HAVE BEEN NOTED ACROSS THE EVENTS. THE SAME LOT NUMBER (LOT# M90191117) WAS NOTED IN THE EVENTS REPORTED IN 2100090000-2020-8008 (MFR REPORT NUMBERS 2955842-2020-10519) AND 2100090000-2020-8009 (MFR REPORT NUMBER ). THIS CONTACT CONFIRMED THAT NONE OF THE INSTRUMENTS WILL BE RETURNED. ¿THERE WAS NO HARM TO THE PATIENT IN ANY OF THE REPORTED EVENTS. THERE WAS NO PART OF THE DEVICE THAT WAS RETAINED BY THE PATIENT IN ANY OF THE REPORTED EVENTS.¿ ¿YES, IN EACH INSTANCE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY.¿ ¿YES, THE INSTRUMENT WAS USED WITH THE ETHICON HAND PIECE (MODEL HP054) AND THE ETHICON ENDO-SURGERY GENERATOR G11 (MODEL GEN11).¿ ¿NO ADDITIONAL INFORMATION ON THE STATE OF THE GENERATOR/TONES WERE REPORTED BY THE USER. ¿JOHNS HOPKINS HOSPITAL DOES NOT RELEASE VIDEO PER POLICY AND FOR PATIENT PRIVACY LAW COMPLIANCE.¿ THE INSTRUMENT WAS NEVER USED ON CARTILAGE, BONE, OR HARD OBJECTS. THE INSTRUMENT WAS NEVER USED FOR CONTRACEPTIVE TUBAL OCCLUSIONS. THE INSTRUMENT WAS USED THROUGH THE STANDARD 8MM CANNULA. ¿THE INSTRUMENT WAS NOT CLEANED INTEROPERATIVELY BEFORE THE BREAK BUT IN ALL INSTANCES HAPPENED EARLY IN THE CASE.¿ THE SELF-TEST WAS PERFORMED OUTSIDE OF THE PATIENT. ¿NO ISSUES WERE IDENTIFIED DURING THE SELF-TEST. PER PROTOCOL, IF THERE HAD BEEN, IT WOULD NOT HAVE BEEN USED.¿ NO RESISTANCE WAS NOTED BY THE USER BEFORE THE INSTRUMENT WAS REMOVED. THE SURGEON WAS ALWAYS INFORMED OF INSTRUMENT REMOVAL AND THE JAWS WERE CLOSED PRIOR TO INSTRUMENT REMOVAL PER PROTOCOL. NO OTHER TOOLS WERE USED THAN THE SUPPLIED SINGLE-USE WRENCH FOR ASSEMBLY/DISASSEMBLY OF THE INSTRUMENT. ¿THE JAWS WERE CLOSED WHEN INSERTING/DETACHING PER PROTOCOL.¿ THERE WAS NO ATTEMPT TO BEND/SHARPEN THE BLADE.¿ ¿PRESSURE WAS NOT EVER APPLIED BETWEEN THE BLADE AND CLAMP ARM WITHOUT HAVING TISSUE BETWEEN THEM.¿ ¿THE INSTRUMENT WAS NOT ACTIVATED FOR A PROLONGED PERIOD OF TIME AGAINST A SOLID SURFACE.¿ ¿THE INSTRUMENT WAS NOT REPROCESSED BEFORE USE.¿ AN IMAGE WAS PROVIDED OF THE INSTRUMENT POST BREAKAGE. THE PICTURE DEPICTS A HARMONIC ACE INSTRUMENT WITH A BROKEN BLADE. THE MISSING FRAGMENT(S) ARE NOT VISIBLE IN THE PICTURES. NO OTHER ABNORMALITIES OR ISSUES ARE VISIBLE IN THE PHOTO." }, { "mdr_text_key": "321676350", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "225930938", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE HARMONIC ACE INSTRUMENT WILL NOT BE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE SYSTEM NUMBER USED WAS NOT PROVIDED. THEREFORE, AN INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. FAILURE ANALYSIS CANNOT BE PERFORMED AS THE PRODUCT WILL NOT BE RETURNED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE BLADE SHEARED OFF AND FELL INSIDE THE PATIENT. THE FALLEN HARMONIC ACE BLADE WAS RETRIEVED DURING THE SAME PROCEDURE, AND AT THIS TIME IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. ALTHOUGH THERE WAS NO PATIENT INJURY, THE PRODUCT MALFUNCTION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE WERE TO RECUR. THE OTHER EVENTS WITH THE SAME REPORTED ISSUE THAT WERE NOTED BY THE REPORTER DURING FOLLOW-UP ARE BEING SUBMITTED UNDER REPORTS WITH THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN OR UNAVAILABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. THE INFORMATION IS UNKNOWN. FULL PRODUCT INFORMATION IS NOT AVAILABLE." }, { "mdr_text_key": "225930939", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE BLADE FELL OFF THE INSTRUMENT AND INSIDE THE PATIENT. 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 FRAGMENT WAS RETRIEVED WITH LAPAROSCOPIC GRASPER DURING THE SAME PROCEDURE. THE FRAGMENT WAS INTACT. THE INSTRUMENT WAS IN USE FOR 2 HOURS PRIOR TO THE ISSUE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE INSTRUMENT TO BREAK AND THE FRAGMENT FALLING ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE. THE SURGEON WAS PERFORMING A VEIN DISSECTION WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THERE WAS NOT ANY FUNCTIONAL ISSUE WITH THE INSTRUMENT. THE INSTRUMENT DID NOT ENCOUNTER ANY HARD MATERIAL OR COLLIDE WITH ANY OTHER INSTRUMENT. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT. THE INSTRUMENT WILL NOT BE RETURNED FOR ISI EVALUATION. THE REPORTER MENTIONED THAT THE SAME THING HAPPENED TWO TIMES IN (B)(6) 2019 AND TWO TIMES IN (B)(6) 2020." } ], "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": "07/07/2020;11/10/2020;05/24/2023" } ] }