{ "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": "2955842-2022-13636", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220824", "manufacturer_address_2": "", "pma_pmn_number": "K101077", "date_of_event": "20220727", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20220824", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20121215", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "440510", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220824", "brand_name": "DA VINCI", "generic_name": "CAMERA HEAD ASSEMBLY, HD, GLENAIR", "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": "655858-03", "catalog_number": "655858", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874112755", "udi_public": "(01)00886874112755", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Misfocusing", "Misfocusing" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/12/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250729", "health_professional": "", "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": "20220824", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "64 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Post Operative Wound Infection", "Abscess", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20220727", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15283857", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220727", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "298493775", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FSE WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE CONFIRMED THAT FAILURE OF THE CAMERA HEAD TO FOCUS. THE CAMERA HEAD WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE CAMERA HEAD INVOLVED WITH THIS COMPLAINT. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. THE SURGEON STATED THAT THE PROLONGED PROCEDURE TIME MAY HAVE CONTRIBUTED TO THE POST-OPERATIVE PELVIC ABSCESS. THE PATIENT HAD UNDERLYING MEDICAL CONDITIONS (INTERSTITIAL PNEUMONIA AND TREATMENT WITH CYCLOSPORINE, AN IMMUNOSUPPRESSIVE DRUG) WHICH LIKELY CONTRIBUTED TO THE SSI AS WELL. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE CAMERA HEAD IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO FOCUS THE ENDOSCOPE. THE PATIENT WAS ANESTHETIZED AND PORTS WERE IN PLACE AT THAT TIME. THE PATIENT ALSO HAD INTERSTITIAL PNEUMONIA PRIOR TO SURGERY. THE CUSTOMER PERFORMED TROUBLESHOOTING WITH ISI TECHNICAL SUPPORT, BUT THE CAMERA HEAD WAS STILL UNABLE TO FOCUS. A REPLACEMENT CAMERA HEAD WAS REQUIRED, AND IT TOOK 3 HOURS FOR THE NEW CAMERA HEAD TO ARRIVE AND BE INSTALLED. AS A RESULT, THE PATIENT WAS UNDER ANESTHESIA FOR A PROLONGED DURATION. THE SURGERY PROCEEDED WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS, BUT ON POST-OPERATIVE DAY 6 OR 7, THE PATIENT DEVELOPED A PELVIC ABSCESS. THE PATIENT UNDERWENT A CT SCAN AND HAD BLOOD CULTURES, URINE CULTURES AND BLOOD TESTS DONE. THE INFECTION WAS TREATED WITH ANTIBIOTICS AND THE PATIENT'S HOSPITALIZATION WAS PROLONGED AS A RESULT. THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "298493776", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO FOCUS THE ENDOSCOPE. AT THE TIME THE ISSUE OCCURRED, THE PATIENT WAS ANESTHETIZED AND PORTS WERE PLACED. THE CUSTOMER HAD POWER CYCLED THE SYSTEM, TRIED TO FOCUS BOTH FROM THE SURGEON SIDE CONSOLE (SSC) AND CAMERA HEAD BUTTONS, AND PERFORMED 3D CALIBRATION BUT THE FOCUSING ISSUE WAS STILL NOT IMPROVED. THE CUSTOMER CONTACTED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) FOR TROUBLESHOOTING ASSISTANCE AND WAS ADVISED TO TIGHTEN THE CAMERA CABLE AND TRY TO REFOCUS AGAIN. THE CUSTOMER REPORTED THAT THE CAMERA CABLE WAS NOT LOOSE AND MECHANICAL SOUND WAS HEARD WHEN HE PRESSED ON THE FOCUS BUTTON OF THE CAMERA HEAD. THE IMAGE STILL COULD NOT BE FOCUSED. THE CUSTOMER WAS ADVISED THAT THE ISSUE MAY BE FROM THE CAMERA HEAD. THE PATIENT REMAINED ANESTHETIZED FOR APPROXIMATELY THREE HOURS BEFORE THE BACKUP CAMERA HEAD ARRIVED. AFTER THE CAMERA HEAD WAS REPLACED BY AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE), THE PROCEDURE WAS RESUMED AND COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO INTRAOPERATIVE PATIENT HEALTH DAMAGE OBSERVED; HOWEVER, THE PATIENT ORIGINALLY HAD INTERSTITIAL PNEUMONIA, SO THE ANESTHESIOLOGIST WANTED TO SHORTEN THE ANESTHESIA TIME AS MUCH AS POSSIBLE. THE CUSTOMER WILL CONTINUE TO MONITOR THE PATIENT'S CONDITION DUE TO EXTENDED OPERATION TIME AND UNDERLYING CONDITION OF INTERSTITIAL PNEUMONIA. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER HAD TO WAIT FOR THE REPLACEMENT OF A BACKUP CAMERA HEAD TO RESUME THE PROCEDURE. ADDITIONAL ANESTHESIA WAS ADMINISTERED DUE TO THE PROLONGED PROCEDURE TIME. THERE WAS NO INJURY TO THE PATIENT DUE TO THE PROCEDURE. POST-OPERATIVELY, THE PATIENT HAD A PELVIC ABSCESS ON THE 6TH OR 7TH DAY AFTER THE PROCEDURE. THE PATIENT UNDERWENT A CT SCAN, BLOOD TEST, BLOOD CULTURE AND URINE CULTURE. THE INFECTION WAS TREATED WITH CEFTRIAXONE 2 G Q24HR FROM AUGUST 3-8TH AND CEFALEXIN 3T FROM AUGUST 9-23RD. THE DOCTORS BELIEVE THAT THE CAUSE OF THE PELVIC ABSCESS WAS DUE TO A SURGICAL SITE INFECTION (SSI). IN ADDITION, THE PROLONGED PROCEDURE TIME MAY HAVE CONTRIBUTED TO THE POST-OPERATIVE COMPLICATION. THE PATIENT WAS ON TREATMENT WITH CYCLOSPORINE (AN IMMUNOSUPPRESSIVE DRUG) PREVIOUSLY, BUT THE DRUG WAS STOPPED BEFORE AND AFTER THE SURGERY. NO PHOTO IMAGES OR VIDEO RECORDING WERE AVAILABLE FOR REVIEW. DEMOGRAPHIC INFORMATION WAS ENQUIRED BUT NOT PROVIDED." }, { "mdr_text_key": "332281536", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "332281537", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 12-SEP-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM FAILURE ANALYSIS OF THE CAMERA: FAILURE ANALYSIS CONFIRMED THAT THE CAMERA WAS UNABLE TO ADJUST THE FOCUS. THERE WAS MECHANICAL SHOCK RESULTING IN DAMAGED STAGE ASSEMBLY AND DAMAGED HOUSING COMPONENTS WHICH REQUIRE REPAIR/REPLACEMENT. THE LIGHT CABLE WAS DAMAGED AS WELL REQUIRING REPLACEMENT." } ], "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": "10/11/2022" } ] }