{ "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": "2955842-2012-00170", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20120502", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20120221", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Foreign", "Health Professional", "User facility" ], "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": "20120502", "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": "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "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": "20120502", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Injury" ] } ], "distributor_city": "", "date_report": "20130110", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2557008", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120221", "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": "17410012", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE THE PATIENT DEVELOPED A POSTSURGICAL COMPLICATION. THE PATIENT HAD ABSCESS IN THE PELVIS. THE SITE HAS ADVISED AN ANASTOMOSIS INSUFFICIENCY CAUSED THE PATIENT INJURY. THE DELAY IN REPORTING IS DUE TO VAGUE EVENT DESCRIPTION AND ROOT CAUSE DETERMINATION BY THE USER FACILITY. AS INDICATED, AN INVESTIGATION IS ONGOING, AND UNTIL FURTHER ROOT CAUSE DETERMINATION CAN BE CONFIRMED, THIS EVENT SHALL BE REPORTED." }, { "mdr_text_key": "17643290", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN INVESTIGATION BY HYGIENE SPECIALIST AT (B)(6) TESTED THE INSTRUMENTS USED IN THE REPORTED CASE, THE TEST CONCLUDED TO FIND NO MALFUNCTION OF INTUITIVE SURGICAL INSTRUMENTS. THE INSTRUMENTS WERE ALSO TESTED FOR BACTERIAL CONTAMINATION, THE TEST REVEALED NO CONTAMINATION OF INTUITIVE SURGICAL INSTRUMENTS. THE HYGIENE SPECIALIST COULD NOT MAKE A DEFINITE ROOT CAUSE DETERMINATION, BUT DID CONCLUDE AFTER EXTENSIVE ANALYSIS OF THE REPORTED EVENT, THAT THE POST-SURGICAL COMPLICATIONS OF THE PATIENT ARE NOT A RESULT OF ANY POTENTIALLY CONTAMINATED INSTRUMENTS. MICROBIOLOGICAL FINDINGS OF THE POST-SURGERY EXAMINATIONS AND AN ANASTOMOSIS INSUFFICIENCY IN THE OPERATING FIELD CONFIRMED THIS. THE HYGIENE SPECIALIST FURTHER NOTED THAT THE INFECTION CAUSING BACTERIA IN THE PELVIC CAVITY WAS DETERMINED TO BE A MIXED FLORA, A.O. E. COLI, BUT THE ACCOUNT CONFIRMED THERE WAS NO INTESTINE LEAKAGE. INFORMATION RECENTLY RECEIVED FROM (B)(6) STATED THAT THE ABSCESS EXPERIENCED BY THIS SITE WAS FOUND TO BE RELATED TO LEAK IN ANASTOMOSIS IN WHICH THEY HAVE REPORTED AS A KNOWN COMPLICATION FOR PROSTATECTOMY PROCEDURES PERFORMED AND NOT A DEFICIENCY OF THE DA VINCI SURGICAL SYSTEM OR THE ASSOCIATED INSTRUMENTS OR ACCESSORIES. OUR CLINICAL RESEARCH SUPPORTS THIS FINDING AND INDICATES THAT INSUFFICIENCIES IN ANASTOMOSIS CAN OCCUR REGARDLESS OF TECHNIQUE USED IN ORDER TO ACHIEVE ANASTOMOSIS IN ROBOTIC ASSISTED LAPAROSCOPIC PROCEDURES. PLEASE SEE CITED ARTICLE: WILLIAMS, S. B., M. ALEMOZAFFAR, ET AL. (2010). RANDOMIZED CONTROLLED TRIAL OF BARBED POLYGLYCONATE VERSUS POLYGLACTIN SUTURE FOR ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY ANASTOMOSIS: TECHNIQUE AND OUTCOMES. EUROPEAN UROLOGY 58(6): 875-881." }, { "mdr_text_key": "10390423", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." } ], "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" } ] }