{ "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": "2955842-2013-04989", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110331", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562221", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "brand_name": "DA VINCI S 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": [ "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": "20250818", "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": "20131101", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Atrial Fibrillation", "Incontinence", "Ventricular Tachycardia", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444458", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "11240423", "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 DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "3857044", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY ON (B)(6) 2011 DUE TO PROSTATE CANCER. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED INCLUDED THE PATIENT'S ATTORNEY CLAIM FORM. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. ACCORDING TO THE INFORMATION IN THE PATIENT'S OPERATIVE REPORT, THE SURGEON ENCOUNTERED EXTENSIVE ADHESIONS THROUGHOUT THE PATIENT'S PELVIS DURING CREATION OF THE PATIENT'S PORT SITES. THE ADHESIONS WERE TAKEN SHARP AND CAUTERY DISSECTION. AFTER THE ADHESIONS WERE TAKEN DOWN, THE DA VINCI SURGICAL SYSTEM WAS DOCKED TO THE PATIENT. REPORTEDLY, THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THE ESTIMATED BLOOD LOSS WAS 250CC. ACCORDING TO THE PATIENT'S CLAIM FORM, ON (B)(6) 2011 THE PATIENT UNDERWENT EXPLORATORY CELIOTOMY WITH EXTENSIVE LYSIS OF ADHESIONS AND SMALL BOWEL RESECTION. THE PATIENT UNDERWENT A CT SCAN WITH ORAL CONTRAST DOCUMENTING CONTRAST EXTRAVASATION INTO THE RIGHT UPPER QUADRANT. THERE WERE TWO SMALL AREAS WHERE THE SUCCUS WAS DRAINING AND A LARGE NEAR COMPLETE DISRUPTION OF THE SMALL INTESTINE VIA MID BOWEL. REPORTEDLY, POSTOPERATIVELY THE PATIENT DEVELOPED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE PATIENT WAS MARKEDLY ACIDOTIC INITIALLY. ALTHOUGH THAT IMPROVED WITH SOME TREATMENT BOTH FROM A RESPIRATORY STANDPOINT AS WELL AS THE ADDITION OF BICARBONATE. THE PATIENT APPEARED TO BE VOLUME DEPLETED AND LIKELY SEPTIC AS WELL. THE PLAN WAS TO GIVE THE PATIENT TWO DOSES OF IV DIGOXIN, IV AMIODARONE, FLUID RESUSCITATION. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE PATIENT REQUIRED HOMEHEALTH CARE AND WAS RELEASED FROM HOME HEALTHCARE ON (B)(6) 2011. THE CLAIM FORM INDICATED THAT THE PATIENT'S MEDICAL RECORDS FOR (B)(6) 2011 INDICATED THAT THE PATIENT DID NOT RECEIVE RADIATION THERAPY AFTER UNDERGOING THE ROBOTIC PROSTATECTOMY. THE PATIENT REQUIRED 1-2 PADS PER DAY AND EXPERIENCED PROBLEMS WITH ERECTIONS. THE PATIENT'S PSA HAD BEEN LOW SINCE HIS PROSTATE CANCER TREATMENT WAS STARTED. HE DOES HAVE A GOOD APPETITE, HIS BOWELS ARE MOVING NORMALLY. THE PATIENT WAS TO RETURN IN 3 MONTHS. ACCORDING TO THE CLAIM FORM, ON (B)(6) 2011 THE PATIENT COMPLAINED OF URINARY CONTROL OR INCONTINENCE, AND WAS WEARING PROTECTIVE PADS. ON (B)(6) 2012, THE PATIENT WAS HAVING PROBLEMS WITH URINARY CONTROL OR INCONTINENCE AND REQUIRED PROTECTIVE PADS - WEARS 1-2 PADS PER DAY. THE PATIENT WAS ADVISED TO FOLLOW UP IN 4 MONTHS. ON (B)(6) 2012, IT WAS NOTED THAT THERE WAS NO SIGNIFICANT INCONTINENCE. FROM (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PARTIAL VERSUS COMPLETE SMALL BOWEL OBSTRUCTION. AS OF (B)(6) 2012, THE CLAIM FORM INDICATED NO SIGNIFICANT INCONTINENCE, NO BOTHERSOME SYMPTOMS. THE PATIENT WAS ADVISED TO FOLLOW UP IN 4 MONTHS." } ], "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": "" } ] }