{ "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": "2955842-2013-03163", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110802", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410202", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI 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": "IS1200 A4.3P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "97", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Hematoma", "Myocardial Infarction", "Nausea", "Chills", "Anxiety", "Discomfort", "Malaise", "Test Result" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305660", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "21317697", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2011. THE DOCUMENTATION PROVIDED STATES THAT THE PATIENT DEVELOPED A HEMATOMA AFTER UNDERGOING THE SURGICAL PROCEDURE. APPROXIMATELY ONE MONTH PRIOR, THIS PATIENT HAD UNDERGONE A CHOLECYSTECTOMY PROCEDURE WITH NO COMPLICATION. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED IN THE OPERATIVE REPORT OF THE DA VINCI PARTIAL NEPHRECTOMY PROCEDURE PERFORMED ON (B)(6) 2011. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT'S PERITONEAL CONTENTS WERE INSPECTED AND NO INJURIES OR DEFECTS WERE FOUND. THE PATIENT WAS REPORTEDLY SENT TO THE RECOVERY ROOM IN GOOD CONDITION. DURING THE COURSE OF THE PATIENT'S HOSPITALIZATION, THE PATIENT HAD A REPORTED COMPLAINT OF RETROSTERNAL DISCOMFORT ON (B)(6) 2011. THE PATIENT WAS EVALUATED AND FOUND TO HAVE A NON-Q MYOCARDIAL INFARCTION. ON (B)(6) 2011, THE PATIENT UNDERWENT A LEFT HEART CARDIAC CATHETERIZATION PROCEDURE WITH SELECTIVE RIGHT AND LEFT CORONARY ANGIOGRAPHY AND LEFT VENTRICULOGRAPHY. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL WITH REPORTED COMPLAINTS OF EXTREME ANXIETY. THE PATIENT'S MEDICAL RECORDS INDICATE THAT SHE WAS MANAGED MEDICALLY AND SHE IMPROVED. THE PATIENT WAS DISCHARGED HOME THAT SAME DAY WITHOUT ANY COMPLICATIONS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR LOWER ABDOMINAL PAIN AND AN ELEVATED WHITE BLOOD CELL COUNT. THE PATIENT REPORTED A ONE-WEEK HISTORY OF CHILLS, GENERALIZED MALAISE, NAUSEA WITHOUT VOMITING, ABDOMINAL PAIN THAT WAS WORSE ON THE LEFT SIDE, AND FREQUENT STOOLS. A CT SCAN PERFORMED ON THE PATIENT SHOWED WHAT APPEARED TO BE A LARGE LEFT PERINEPHRIC ABSCESS. ON (B)(6) 2011, THE PATIENT UNDERWENT CT GUIDED DRAINAGE OF THE SUSPECTED ABDOMINAL ABSCESS. DURING THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE AN INFECTED HEMATOMA RATHER THAN A DIVERTICULAR ABSCESS. A PERCUTANEOUS CATHETER WAS PLACED FOR DRAINAGE AND SHE WAS DISCHARGED HOME THAT SAME DAY ON ORAL ANTIBIOTICS. ON (B)(6) 2012, THE PATIENT WAS EVALUATED FOR MICROSCOPIC HEMATURIA. THE PATIENT UNDERWENT A CYSTOSCOPY PROCEDURE. THE PATIENT WAS FOUND TO HAVE NEGATIVE HEMATURIA. THE PHYSICIAN STATED IN THE PATIENT'S MEDICAL RECORDS THAT SHE WAS DOING REASONABLY WELL. NO ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "21268721", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED A HEMATOMA AS A RESULT OF UNDERGOING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE." } ], "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": "" } ] }