{ "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": "2955842-2012-00215", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20120517", "manufacturer_address_2": "", "pma_pmn_number": "K070684", "date_of_event": "20100901", "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": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120803", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120517", "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": "IS2000 A4.3P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "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": "20120517", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Incontinence", "Nerve Damage", "Pain", "Urinary Tract Infection", "Hernia", "Disability" ] } ], "distributor_city": "", "date_report": "20130110", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2579296", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120427", "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": "10450760", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "14885791", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI PROSTATECTOMY PROCEDURE WAS FOUND POSTED ON THE (B)(4): I WAS DIAGNOSED WITH A T1CNXMX GLEASON 6 ADENOCARCINOMA, 2 OF 6 BIOPSIES IN (B)(6) 2010. THOUGHT ROBOTIC SURGERY WOULD BE THE BEST TYPE OF SURGERY AVAILABLE. THE FIRST UROLOGIST BENT OVER BACKWARDS TO SELL THE ROBOTIC SURGERY AND MY WIFE AND I AGREED BASED ON THE FAST HEALING TIME AS ALL OTHER OUTCOMES WOULD BE THE SAME AS OPEN SURGERY. BASED ON MY DIAGNOSIS, I THOUGHT I WOULD HAVE AN EXCELLENT CHANCE OF CURE AND A FAST RECOVERY. DA VINCI WEBSITE AND THE SURGEON ALLUDED TO GREAT EXPECTATIONS, I HAD THE SURGERY IN (B)(6) 2010. OUTCOME WAS ATROCIOUS, URINARY TRACT DAMAGE, UTI, BLADDER AND KIDNEY INFECTION, 12 MONTHS OF PERINEAL PAIN AND PHYSIO TO HELP TREAT IT AND STILL REQUIRE PHYSIO OCCASIONALLY (THE PHYSIO MAN THOUGHT DAMAGE WAS CAUSED BY NERVE DAMAGE RELATED TO POSTURAL ISSUES DURING SURGERY), INCONTINENCE, IMPOTENCE AND AT LASTLY AN INCISIONAL HERNIA FROM A VERY LARGE OVERSIZED PORT ABOVE MY NAVEL (6CM LONG OR 2.5 INCHES) DA VINCI WEBSITE SAYS 1/2 INCH (12MM) PORTS. NOW MY STOMACH LOOKS VERY DISTORTED FROM HAVING A VERY LARGE MESH INSERTED TO REPAIR THE HERNIA AND I NOW SPORT A 125MM (5 INCH) SCAR HORIZONTALLY ABOVE MY NAVEL. TIME OFF WORK TO DATE TO INITIALLY HAVE THE SURGERY AND FOLLOW UP SURGERY FOR THE HERNIA IS APPROXIMATELY 14 WEEKS. MEDICAL OUT OF POCKET COSTS NOW EXCEED (B)(6) PLUS LOST INCOME FOR 14 WEEKS. NONE OF MY EXPECTATIONS WERE MET BY THIS SURGERY AND THE SURGEON DIDN'T KNOW AND COULDN'T LOGICALLY EXPLAIN WHY IT ALL HAPPENED. HE WAS AT LEAST VERY HONEST AND I APPRECIATE THAT. THE OUTCOME IS DEVASTATING AND NOW IT SEEMS MY PSA IS INCREASING ALBEIT IT IS NOW AT .03UG/L WHEREAS FOR 12 MONTHS IT WAS .01UG/L. NOW I AM BEING TOLD IT IS POSSIBLE CIRCULATING KALLIKREINS. FUNNY IT WASN'T THERE IN THE FIRST 12 MONTHS. MY QUALITY OF LIFE IS LOW, DRUG CONTROLLED CONTINENCE AND ED ISSUES LINGER. I CONTINUALLY REGRET THE DAY I DECIDED TO HAVE ROBOTIC SURGERY." }, { "mdr_text_key": "15276632", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SYSTEM LOGS OF THE DA VINCI SYSTEM WERE REVIEWED AND NO ERRORS WERE OBSERVED WHICH INDICATE THAT THERE WERE ISSUES WITH THE SYSTEM. THE ROOT CAUSE OF THE POST SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT IS CURRENTLY UNDETERMINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ABOUT THE EVENT, BUT THE CUSTOMER HAS YET TO PROVIDE FURTHER DETAILS. AS OF MAY 16, 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." } ], "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": "01/10/2013" } ] }