{ "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": "2955842-2013-03682", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130919", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110824", "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": "20130919", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "474287", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130919", "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 A6.0P8", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20130919", "sequence_number_treatment": [ "DA VINCI SI SURG SYS INSTRMNTS, ACCESSIES & ESU." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Dyspnea", "Extravasation", "Hematoma", "Nausea", "Urinary Retention", "Vomiting", "Ascites", "Abdominal Distention" ] } ], "distributor_city": "", "date_report": "20130820", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3358032", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130820", "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": "15336422", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) 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. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS FOLLOWING A DA VINCI SI RADICAL PROSTATECTOMY AND BILATERAL PELVIC LYMPHNODE DISSECTION PROCEDURE." }, { "mdr_text_key": "15026913", "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 OF A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL PROSTATECTOMY AND BILATERAL PELVIC LYMPHNODE DISSECTION PROCEDURE ON (B)(6) 2011, DUE TO A PRE-OPERATIVE DIAGNOSIS OF PROSTATE CARCINOMA. APPROXIMATELY 24 HOURS FOLLOWING THE SURGICAL PROCEDURE THE PATIENT DEVELOPED ABDOMINAL DISTENSION AND EXPERIENCED ABDOMINAL PAIN. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ACUTE RENAL FAILURE, HYPOXIA, URINARY RETENTION AND HYPOTHERMIA. THERE WAS NO INDICATION IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE AND WAS SENT TO THE RECOVERY ROOM IN STABLE CONDITION. DURING THE PATIENT'S POST-OPERATIVE HOSPITALIZATION, THE PATIENT COMPLAINED OF ABDOMINAL PAIN, EXPERIENCED SHORTNESS OF BREATH, NAUSEA AND VOMITING AND DEVELOPED POST-OPERATIVE ILEUS AND LEUKOCYTOSIS. ON (B)(6) 2011 THE PATIENT UNDERWENT AN ABDOMINAL AND PELVIS CT SCAN. THE CT SCAN SHOWED THAT THE PATIENT HAD DEVELOPED COLONIC ILEUS, DISTENSION, AND HAD POSSIBLE URINARY RETENTION. THE CT SCAN ALSO SHOWED THAT THE PATIENT HAD A HEMATOMA ALONG THE RIGHT PELVIC SIDEWALL. A CHEST X-RAY WAS NORMAL WITH NO SIGN OF PNEUMONIA OR PULMONARY EDEMA. ON (B)(6) 2011, THE PATIENT UNDERWENT AN ABDOMINAL AND PELVIC CT SCAN. THE ABDOMINAL CT SCAN SHOWED THAT THE PATIENT'S HEART WAS UNREMARKABLE AND THE LUNG BASES DEMONSTRATED MINIMAL BIBASILAR SUBSEGMENTAL ATELECTASIS. THE PELVIC CT SCAN SHOWED THAT THE PATIENT HAD GENERALIZED ILEUS, POST-SURGICAL CHANGES WITH EVOLVING INTRAPERITONEAL AND EXTRAPERITONEAL HEMATOMAS AND AN INCREASED INTRAPERITONEAL FLUID AND PROBABLE EXTRAVASATION OF EXCRETED CONTRAST IN THE PELVIS. REPORTEDLY, THE FINDINGS WERE CONCERNING FOR BLADDER/URETHRAL DEFECT. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT UNDERWENT A CYSTOGRAM ON (B)(6) 2011. THE CYSTOGRAM SHOWED THAT THE PATIENT HAD INTRA AND EXTRAPERITONEAL CONTRAST EXTRAVASATION THAT APPEARED TO ORIGINATE FROM THE BLADDER BASE/PROSTATIC URETHRA REQUIRING FURTHER EVALUATION WITH A CT SCAN. THE CT SCAN SHOWED IMPROVEMENT IN THE DEGREE OF HEMORRHAGE THROUGHOUT THE PELVIS AND LOWER ABDOMEN AND NO FREE AIR WAS LOCATED IN THE PELVIS AND THE POST-OP ELIEUS APPEARED STABLE. ON (B)(6) 2011 THE PATIENT UNDERWENT A CT GUIDED ABSCESS DRAIN FOR URINE ASCITES. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS WITHOUT IMMEDIATE COMPLICATIONS. A FOLLOW-UP ABDOMINAL AND PELVIC CT SCAN ON (B)(6) 2011 SHOWED THAT THE PATIENT'S LUNG BASES WERE CLEAR AND THE PATIENT HAD NO SIGNIFICANT MESENTERIC OR RETROPERITONEAL ADENOPATHY. THE PATIENT'S BOWEL LOOPS WERE NON-DILATED AND THERE WAS NO SIGNIFICANT FREE AIR NOTED. NO ADDITIONAL MEDICAL RECORDS WERE PROVIDED TO ISI AFTER THAT." } ], "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": "" } ] }