{ "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": "2955842-2013-03164", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20090211", "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": "410204", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": "IS2000 A5.1P8", "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": "20250815", "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 S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "54 YR", "patient_sex": "", "patient_weight": "95", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Edema", "Nausea", "Pain", "Discharge" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305666", "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": "20865447", "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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED DA VINCI SI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED POST-SURGICAL COMPLICATIONS AS A RESULT OF UNDERGOING A DA VINCI PROSTATECTOMY PROCEDURE." }, { "mdr_text_key": "20633373", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE DOCUMENTATION PROVIDED STATES THAT THE PATIENT DEVELOPED AN ABSCESS AS A RESULT OF UNDERGOING THE SURGICAL PROCEDURE AND WAS HOSPITALIZED. THE PATIENT'S OPERATIVE REPORT FOR (B)(6) 2009, INDICATED THAT HE UNDERWENT A RADICAL PROSTATECTOMY, FOLLOWED BY A BILATERAL PELVIC LYMPH NODE DISSECTION. THE PATIENT HAD BEEN DIAGNOSED WITH ADENOCARCINOMA OF THE PROSTATE. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED ON THE OPERATIVE REPORT. THE OPERATIVE REPORT ALSO NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY ON (B)(6) 2009, AND WAS REPORTED TO BE DOING FINE. THE DISCHARGE SUMMARY INDICATED THAT THE PATIENT WAS AFEBRILE, HIS URINE WAS CLEAR, WITH MINIMAL DRAINAGE. HE WAS DISCHARGED WITH A FOLEY CATHETER. ON (B)(6) 2009, THE PATIENT HAD A POST-OPERATIVE FOLLOW-UP APPOINTMENT WITH THE SURGEON. THE PATIENT'S CATHETER WAS REMOVED. THE PATIENT'S PORT SITES LOOKED GOOD. DURING A FOLLOW UP VISIT ON (B)(6) 2009 THE PATIENT REPORTED DYSURIAL PAIN IN HIS RIGHT TESTICLE. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS AND VICODIN FOR PAIN CONTROL. DURING A FOLLOW UP VISIT ON (B)(6) 2009, A CT SCAN WAS PERFORMED AND INDICATED A LEFT INGUINAL MASS CAUSING COMPRESSION OF LOCALIZED VENOUS VASCULATURE WITH EDEMA IN THE LOWER EXTREMITIES. THE PATIENT WAS ADMITTED TO THE HOSPITAL THE FOLLOWING DAY. ON (B)(6) 2009 A DRAIN WAS PLACED TO REMOVE PELVIC FLUID COLLECTION THAT WAS CAUSING LYMPHATIC AND RENAL OBSTRUCTION. THE SWELLING IMPROVED OVERNIGHT AND THE PATIENT WAS DISCHARGED THE NEXT DAY. A FOLLOW-UP APPOINTMENT ON (B)(6) 2009, REVEALED THAT THE PATIENT WAS HEALING WELL FROM SURGERY AND HE DID NOT HAVE URINARY INCONTINENCE. ON (B)(6) 2009, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) AND FOUND TO HAVE A RECURRENT LYMPHOCELE. THE PATIENT WAS TREATED FOR NAUSEA AND PAIN. THE PATIENT REPORTEDLY DECLINED HOSPITALIZATION. ON (B)(6) 2009, THE PATIENT HAD ANOTHER FOLLOW-UP APPOINTMENT WITH THE SURGEON WHO PERFORMED THE DA VINCI PROSTATECTOMY PROCEDURE. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, HE WAS DOWN TO PUTTING OUT ABOUT 200 CC EVERY 2 HOURS OUT OF HIS JP DRAIN. THE MEDICAL RECORD ALSO NOTED THAT WHEN THE PATIENT PUSHES BETADINE IN, HE CAN ONLY GET A FEW CC BEFORE IT STARTS TO DRAIN OUT AROUND, SO THE SPACE IS PROBABLY ALMOST COMPLETELY OBLITERATED AT THIS POINT. THE PATIENT WAS SCHEDULED TO SEE A RADIOLOGIST IN 3 DAYS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }