{ "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": "2955842-2012-00172", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20120419", "manufacturer_address_2": "", "pma_pmn_number": "", "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": [ "Other", "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": "20120420", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120419", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC ELECTROSURGICAL 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": "0", "model_number": "", "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": [ "Device Disinfection Or Sterilization Issue" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20120419", "sequence_number_treatment": [ "DA VINCI SURG SYSTEM, INSTRUMENT AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess" ] } ], "distributor_city": "", "date_report": "20120320", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2542327", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120615", "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": "2693588", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, INTUITIVE SURGICAL WAS PROVIDED A LETTER SENT TO (B)(6) FROM (B)(6), ALLEGING PROLONGED PROCEDURES UP TO 11 HOURS CAN RESULT IN AFFECTS TO THE PATIENT SUCH AS THROMBOSIS, EMBOLISM, COMPARTMENTAL SYNDROME AND HEMATOMAS. ADDITIONALLY, AN ALLEGATION WAS MADE THAT A PATIENT EXPERIENCED AN ABSCESS AFTER A PROCEDURE. THE LETTER ALSO ALLEGED GENERAL PROBLEMS WITH PROPER STERILIZATION OF INSTRUMENTS. NO SITE SPECIFIC INFORMATION WAS PROVIDED WITHIN THE BODY OF THIS LETTER. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE AUTHOR OF THE LETTER, (B)(6) AND STAFF, BOTH VIA EMAIL AND PHONE; HOWEVER, AS OF THE DATE OF THIS REPORT NO RETURNED COMMUNICATION HAS BEEN RECEIVED." }, { "mdr_text_key": "9858271", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE INITIAL AUTHOR OF THE LETTER AND STAFF MEMBERS OF THIS (B)(6) TO GAIN ADDITIONAL INFORMATION REGARDING THESE ALLEGATIONS; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "10101211", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL MADE MULTIPLE ATTEMPTS TO VERIFY THE INFORMATION AS INDICATED IN THE LETTER RECEIVED FROM (B)(4) AND BASED ON THE INVESTIGATION INTUITIVE SURGICAL WAS ABLE TO VERIFY INFORMATION CONCERNING ONLY ONE OF THE ALLEGATIONS, WHICH CONCERNED A PATIENT THAT DEVELOPED AN ABSCESS POST-OP A DA VINCI PROSTATOVESICULECTOMY PROCEDURE. INTUITIVE SURGICAL'S INVESTIGATION IS AS FOLLOWS: ON (B)(6) 2012 INTUITIVE SURGICAL CONTACTED (B)(6) WHO INITIALLY DISTRIBUTED THE DZTIM LETTER TO (B)(4) WHO FORWARDED THE LETTER TO INTUITIVE SURGICAL. (B)(6) WAS OUT OF OFFICE. ON (B)(6) 2012 INTUITIVE SURGICAL CONTACTED PROFESSOR (B)(6) AT THE CLINIC IN (B)(6) WHO IS THE AUTHOR OF THE LETTER. NO RESPONSE WAS RECEIVED. ON (B)(6) 2012, INTUITIVE SURGICAL CONTACTED (B)(6) AT THE (B)(6) AND SHE INDICATED THAT SHE WAS NOT AWARE OF A PATIENT-ABSCESS REPORT AND REFERRED INTUITIVE SURGICAL TO (B)(6) ALSO AT (B)(6). (B)(6) INDICATED THAT SHE DID NOT HAVE ANY INFORMATION CONCERNING THE CLINIC WHERE THE ABSCESS CASE OCCURRED AND SHE RECOMMENDED THAT INTUITIVE SURGICAL PROACTIVELY CONTACTED ALL INTUITIVE SURGICAL CUSTOMERS IN THE AREA AND TO CONTACT (B)(6). MULTIPLE ATTEMPTS TO REACH PROFESSOR (B)(6) WERE MADE FROM (B)(6) 2012 THROUGH (B)(6) 2012, HOWEVER, NO RESPONSE HAS BEEN RECEIVED. HOWEVER, ON (B)(6) 2012 INTUITIVE SURGICAL RECEIVED AN EMAIL FROM A (B)(4) ATTORNEY INDICATING THAT INTUITIVE SURGICAL SHOULD CONTACT (B)(4) CONCERNING THE INCIDENT. INTUITIVE SURGICAL RESPONDED BACK TO (B)(4) INDICATING THAT THERE WOULD BE DIFFICULTY IDENTIFYING THE INCIDENT WITH (B)(4) WITHOUT INFORMATION CONCERNING WHERE THE INCIDENT OCCURRED. ON (B)(4) 2012, INTUITIVE SURGICAL RECEIVED AN EMAIL FROM THE ATTORNEY AT (B)(4) INDICATING THAT THE AFFECTED PATIENT UNDERWENT A DA VINCI PROSTATOVESICULECTOMY PROCEDURE IN JULY 2011 AT (B)(6) AND POST SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT (ABSCESS) WAS TREATED AT CLINICS FOR UROLOGY OF THE (B)(6) IN OCTOBER 2011. ON (B)(4) 2012 INTUITIVE SURGICAL SENT AN EMAIL TO (B)(6). ON (B)(4) 2012, INTUITIVE SURGICAL SENT A REMINDER EMAIL TO (B)(6). ON (B)(4) 2012, INTUITIVE SURGICAL RECEIVED AN EMAIL RESPONSE FROM (B)(6) THE CHIEF PHYSICIAN OF ROBOTIC UROLOGY AT (B)(6) INDICATING THAT REVIEW OF THEIR RECORDS FOUND A DA VINCI PROSTATECTOMY PROCEDURE PERFORMED IN JULY 2011 BY (B)(6) THAT FIT THE PATIENT DESCRIPTION AS INDICATED IN THE INITIAL COMMUNICATION TO INTUITIVE SURGICAL DATED (B)(4) 2012. (B)(6) INDICATED THAT BASED ON THEIR HOSPITAL RECORDS CONCERNING THE SURGICAL PROCEDURE, THERE WERE NO UNUSUAL CONDITIONS THAT OCCURRED DURING OR POST -OP THE SURGICAL PROCEDURE. (B)(6) INDICATED THAT (B)(6) HAD NO PRIOR KNOWLEDGE THAT THE PATIENT WAS BEING TREATED AT (B)(6) 3 MONTHS POST-OP DUE TO POST SURGICAL COMPLICATIONS AND HAD NOT RECEIVED ANY COMMUNICATION FROM (B)(6) CONCERNING THE INCIDENT. (B)(6) INDICATED THAT DUE TO THE UNUSUAL GERM SPECTRUM, (B)(6) REVIEWED THEIR STERILIZATION DOCUMENTATION AND REVIEW OF THE DOCUMENTATION DID NOT REVEAL THE SOURCE OF THE CONTAMINATION. (B)(6) INDICATED THAT DUE TO PATIENT CONFIDENTIALLY, HE IS UNABLE TO PROVIDE ANY OTHER DETAILS CONCERNING THE PATIENT." } ], "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": "09/01/2012" } ] }