{ "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": "HOSPITAL", "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": "2955842-2016-00603", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20160816", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160712", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160816", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "532489", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160816", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS3000 A60P9B", "catalog_number": "", "lot_number": "", "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": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20160816", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Bacterial Infection", "Abscess", "Bacterial Infection" ] } ], "distributor_city": "", "date_report": "20160720", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5878952", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160720", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "55585431", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 08/12/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SITE INITIALLY CLAIMED THAT THE DA VINCI INSTRUMENTS WERE ONE OF FOUR POSSIBLE FACTORS/SOURCES THAT ALLEGEDLY CAUSED THE PATIENT'S POST-OPERATIVE INFECTION. HOWEVER, THE SITE SENT THE ROBOTIC INSTRUMENTS TO A 3RD-PARTY LAB FOR EVALUATION. THE LAB RESULTS REVEALED THAT NO EVIDENCE OF E.COLI WAS FOUND ON ANY OF THE INSTRUMENTS. THE SITE HAS SINCE CONCLUDED THAT THE DA VINCI INSTRUMENTS DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED PATIENT'S POST-OPERATIVE INFECTION. AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE INSTRUMENTS INVOLVED WITH THE REPORTED EVENT. THIS COMPLAINT WAS INITIALLY REPORTED AS AN ADVERSE EVENT SINCE THE SITE ALLEGED THAT THE DA VINCI INSTRUMENTS POSSIBLY CAUSED THE PATIENT'S POST-OPERATIVE INFECTION. BASED ON THE ADDITIONAL INFORMATION OBTAINED FROM THE SITE, THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ALSO, THERE IS NO INDICATION THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY CAUSED THE PATIENT'S POST-OPERATIVE INFECTION. THE SITE PERFORMED AN INTERNAL INVESTIGATION AND CONCLUDED THAT THE DA VINCI INSTRUMENTS USED DURING THE SURGICAL PROCEDURE DID NOT CONTRIBUTE TO THE PATIENT'S POST-OPERATIVE INFECTION. THEREFORE, THE INITIAL MDR OF THIS COMPLAINT IS BEING RETRACTED AS A REPORTABLE EVENT. IF THE INSTRUMENTS ARE RECEIVED BY ISI AND FAILURE ANALYSIS INVESTIGATION FINDS ANY RELATED ANOMALIES, A FOLLOW-UP MDR WILL BE SUBMITTED." }, { "mdr_text_key": "52231955", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S PROCEDURE HISTORY AND SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO SYSTEM RELATED ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION THAT REQUIRED ADDITIONAL MEDICAL INTERVENTION. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S ALLEGED POST-OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "52231956", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON JULY 22, 26, AND 29, 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIME, AN ANTIBIOTIC, INTRAVENOUSLY. THE E. COLI FROM TWO OF THE PATIENTS WERE FOUND TO BE RESISTANT TO THE ANTIBIOTIC. THE THIRD PATIENT REPORTEDLY HAD E. COLI THAT WAS SENSITIVE TO THE ANTIBIOTIC. AT THIS TIME, THE SITE IS PERFORMING AN INTERNAL INVESTIGATION TO IDENTIFY THE CAUSE OF THE REPORTED POST-OPERATIVE COMPLICATIONS. THE SITE HAS REPORTEDLY QUARANTINED ALL OF THE INSTRUMENTS (ROBOTIC AND NON-ROBOTIC) USED DURING THE THREE SURGICAL PROCEDURES AND SENT THEM TO AN OUTSIDE LAB FOR ANALYSIS. THE LAB RESULTS ARE PENDING AS OF THE DATE OF THIS REPORT. THE FOLLOWING INFORMATION PERTAINS TO THE PATIENT WHO EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2016: ON (B)(6) 2016, A PATIENT UNDERWENT A ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (RARP) THAT WAS COMPLETED SUCCESSFULLY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED. IN ADDITION, THERE WERE ALSO NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THE ANASTOMOSIS WAS TESTED PRIOR TO CLOSURE. ON (B)(6) 2016, AN INFECTION/ABSCESS WAS FOUND AROUND THE ANASTOMOSIS, THE BLADDER, AND BOWEL. THAT SAME DAY, THE PATIENT UNDERWENT A LAPAROTOMY PROCEDURE. DETAILS REGARDING WHAT WAS PERFORMED DURING THE LAPAROTOMY PROCEDURE WERE NOT PROVIDED. THE PATIENT'S CURRENT CONDITION WAS NOTED AS BAD. REFER TO THE MDR WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL INFORMATION REGARDING THE ALLEGED POST-OPERATIVE INFECTION RELATED TO THE DA VINCI-SURGICAL PROCEDURE PERFORMED ON (B)(6) 2016. ALSO, REFER TO THE MDR WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL INFORMATION REGARDING THE ALLEGED POST-OPERATIVE INFECTION RELATED TO THE DA VINCI-SURGICAL PROCEDURE PERFORMED ON (B)(6) 2016." } ], "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": "09/09/2016" } ] }