{ "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": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SUNNYVALE", "manufacturer_contact_address_1": "950 KIFER RD", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2013-02539", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130712", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20110609", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94086", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "REED", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94086", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20130712", "manufacturer_contact_f_name": "TABITHA", "device_date_of_manufacturer": "20110501", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "323175", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130712", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI SI", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "3410 CENTRAL 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"mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250825", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20130712", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES.", " DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES.", " NA.", " NA.", " DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "68 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Adhesion(s)", "Emotional Changes", "Emotional Changes", "Fever", "Fever", "Fistula", "Fistula", "Laceration(s)", "Laceration(s)", "Pain", "Pain", "Sepsis", "Sepsis", "Injury", "Injury", "Disability", "Disability", "Confusion/ Disorientation", "Confusion/ Disorientation", "Abdominal Distention", "Abdominal Distention", "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20250305", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SUNNYVALE", "mdr_report_key": "3224947", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20130614", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "94086", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC.,", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "18851937", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT CLAIMED THAT THE ROBOTIC DEVICE IS DEFECTIVE AND THAT DURING THE COURSE OF THE SURGERY, THE PATIENT SUSTAINED SIGNIFICANT INJURIES TO THIS INTESTINES AND SMALL BOWELS BY THE USE OF THE DA VINCI SURGICAL ROBOT. IN ADDITION, THE LEGAL COMPLAINT INDICATED THAT THE ROBOTIC SURGERY WAS CONVERTED TO AN OPEN LAPAROTOMY SURGERY WITH REPAIR OF LACERATIONS AND TEARS OF THE INTESTINES AND SMALL BOWELS. THE LEGAL COMPLAINT ALSO CLAIMED THAT DUE TO THE LACERATIONS AND TEARS TO HIS SMALL BOWELS BY THE DA VINCI ROBOTIC SURGERY, THE PATIENT WOULD SPEND THE NEXT FORTY-FOUR DAYS IN THE HOSPITAL. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT DEVELOPED FEVERS, CONFUSION, ABDOMINAL DISTENSION AND TENDERNESS DUE TO HIS INJURIES, AND ALSO BOUTS OF SEPSIS, SUFFERED ABSCESSES AND GIANT FISTULA. AS A RESULT OF THE INJURIES, THE LEGAL COMPLAINT ALSO INDICATED THAT THE PATIENT HAD TO HAVE MULTIPLE ADDITIONAL OPERATIONS AND HAS SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY." }, { "mdr_text_key": "19214886", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE RISK MANAGEMENT DEPARTMENT OF THE SITE AND THE SURGEON WHO PERFORMED THE DA VINCI SI PROSTATECTOMY PROCEDURE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE RISK MANAGEMENT DEPARTMENT OR THE SURGEON AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2013, ISI OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE PRACTICE ADMINISTRATOR OF THE SURGEON'S OFFICE. THE PRACTICE ADMINISTRATOR INDICATED THAT SHE READ THE OPERATIVE REPORT FOR THE DA VINCI SI SURGICAL PROCEDURE INVOLVED WITH THIS COMPLAINT AND DID NOT SEE ANY DOCUMENTATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. SHE READ ONE PART OF THE OPERATIVE REPORT WHERE THE SURGEON NOTED, I OPENED A PIECE OF SMALL INTESTINE, WHILE TAKING DOWN AN ADHESION. ACCORDING TO THE PRACTICE ADMINISTRATOR, THE OPERATIVE REPORT DID NOT EXPLAIN HOW OR WHY THE PATIENT'S SMALL INTESTINE WAS OPENED. THE SMALL INTESTINE OPENING WAS IMMEDIATELY REPAIRED BY THE SURGEON. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES ON 6/13/2011: EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, A SMALL BOWEL RESECTION, AND INSERTION OF A NEGATIVE PRESSURE DRESSING. ON (B)(6) 2011, THE PATIENT ALSO UNDERWENT THE FOLLOWING PROCEDURES VIA OPEN SURGERY: A SECOND LOOK RE-EXPLORATORY PROCEDURE, DRAINAGE OF ENTEROTOMY, PLACEMENT OF PELVIC DRAINS, AND INSERTION OF A NEGATIVE PRESSURE DRESSING. THE PRACTICE ADMINISTRATOR DID NOT KNOW THE PATIENT'S CURRENT STATUS. THE PATIENT'S MEDICAL RECORDS INDICATED THAT HIS LAST VISIT TO THE HOSPITAL WAS ON (B)(6) 2011. HOWEVER, THE PRACTICE ADMINISTRATOR DID NOT PROVIDE INFORMATION REGARDING THE PATIENT'S HOSPITAL VISIT ON (B)(6) 2011. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011 AND NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUSTAINED INJURIES TO HIS SMALL BOWEL AND INTESTINES WHILE UNDERGOING A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "950 KIFER RD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94086", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/10/2025" } ] }