{ "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": "2955842-2015-00749", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20150515", "manufacturer_address_2": "", "pma_pmn_number": "", "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": [ "Foreign", "Literature", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150515", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "319104", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150515", "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": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20150515", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20150508", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4775009", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150630", "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": "5801353", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE JOURNAL OF ENDOUROLOGY (2015) INTERNET ARTICLE TITLED, EFFECTS OF PREVIOUS HERNIA REPAIR ON EXTRAPERITONEAL ROBOTIC ASSISTED RADICAL PROSTATECTOMY; A MATCHED-PAIR ANALYSE STUDY. (AHMED H. AL-SHAREEF ET AL., 2015). WITHIN THE ARTICLE, A STATEMENT IS NOTED ALLEGING THAT TWO BLADDER INJURIES OCCURRED IN RELATION TO A DA VINCI® RADICAL PROSTATECTOMY PROCEDURE. IN THE ABSTRACT SECTION OF THE JOURNAL ARTICLE, THE FOLLOWING IS STATED, HOWEVER, THERE WERE 2 BLADDER INJURIES WHICH WERE TREATED BY USING V-LOC SUTURE, SIMULTANEOUSLY." }, { "mdr_text_key": "32245162", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED OPERATIVE COMPLICATIONS FROM A CORRESPONDENT AUTHOR FOR THE JOURNAL ARTICLE. THE CORRESPONDENT AUTHOR PROVIDING THE FOLLOWING INFORMATION: EACH OF THE TWO REPORTED BLADDER INJURIES OCCURRED WITH TWO DIFFERENT PATIENTS WHO UNDERWENT A DA VINCI RADICAL PROSTATECTOMY PROCEDURE PERFORMED BY THE SAME SURGEON. THERE WERE NO ALLEGATIONS THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING EITHER DA VINCI SURGICAL PROCEDURE INVOLVED WITH THE BLADDER INJURIES. ACCORDING TO THE CORRESPONDENT AUTHOR, THE TWO BLADDER INJURIES WERE RECOGNIZED DURING PELVIC DISSECTIONS DUE TO BLADDER ADHESIONS WITH PREVIOUSLY PLACED MESH. THESE WERE REPAIRED BY USING CONTINUOUS V-LOC SUTURES SIMULTANEOUSLY AND NO COMPLICATION WAS OBSERVED, DURING FOLLOW-UP. THE BLADDER INJURIES WERE IDENTIFIED INTRA-OPERATIVELY DURING PELVIC LYMPH NODE DISSECTION (PLND). THE SURGEON WHO PERFORMED BOTH DA VINCI SURGICAL PROCEDURES BELIEVED THAT THE BLADDER INJURIES WERE DUE TO PELVIC FIBROSIS AND BLADDER ADHESIONS. THE SURGEON EXPLAINED FURTHER THAT, THESE ADHESIONS DUE TO ANTEROLATERAL, FIXED MESH CAN CAUSE DISLOCATIONS OF THE BLADDER; AND THUS BLADDER INJURIES MAY HAPPEN DURING THE DISSECTIONS IN THE RETZIUS SPACE. THE ESTIMATED BLOOD LOSS OF ONE OF THE SURGICAL PROCEDURES WAS 400 ML. THE ESTIMATED BLOOD LOSS OF THE OTHER DA VINCI SURGICAL PROCEDURE WAS 300 ML. THE CORRESPONDENT AUTHOR INDICATED THAT BOTH PATIENTS ARE CURRENTLY IN STABLE CONDITION ARE DOING VERY WELL WITHOUT ANY SIGNIFICANT ADVERSE EVENTS. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT IS NOW DEEMED NON-REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURES OR CAUSED/CONTRIBUTED TO THE PATIENTS' OPERATIVE COMPLICATIONS. IN ADDITION, THE SURGEON ATTRIBUTED THE PATIENTS' INJURIES TO ANATOMICAL ISSUES. THEREFORE, THE INITIAL MDR SUBMISSION FOR THIS COMPLAINT IS BEING RETRACTED." }, { "mdr_text_key": "13443088", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE FOLLOWING INFORMATION IS UNKNOWN: THE HOSPITAL NAME WHERE THE DA VINCI SURGICAL PROCEDURE WAS PERFORMED, THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE, THE DATE THE SURGICAL PROCEDURE WAS PERFORMED, AND THE CAUSE OF EACH BLADDER INJURY. THERE IS NO CLAIM WITHIN THE ARTICLE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT AN AUTHOR FROM THE JOURNAL ARTICLE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE JOURNAL ARTICLE, A PATIENT SUSTAINED 2 BLADDER INJURIES WHICH WERE REPAIRED WHILE UNDERGOING A DA VINCI RADICAL PROSTATECTOMY PROCEDURE." } ], "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": "07/13/2015" } ] }