{ "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": "2955842-2013-03159", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110421", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410260", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI SI 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": "IS3000 A6.0P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Adhesion(s)", "Nausea", "Vomiting", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305634", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "3834154", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. THE PROVIDED DOCUMENT STATED THAT THE PATIENT SUSTAINED PERFORATIONS OF THE SMALL BOWEL DURING THE SURGICAL PROCEDURE. THE PATIENT'S OPERATIVE REPORT, DATED (B)(6) 2011, NOTED THAT THE PATIENT HAD SIGNIFICANT COMORBIDITIES AND PRIOR SURGERIES OF EXPLORATORY LAPAROTOMY, COLECTOMY, COLOSTOMY AND CLOSURE OF COLOSTOMY. THE SURGEON INCLUDED IN THE OPERATIVE REPORT THAT THE PATIENT HAD SEVERE ADHESIONS PARTICULARLY ON THE LEFT SIDE WHERE THE COLOSTOMY WAS PRESENT. THE ROBOTIC PORTS WERE PLACED IN A SPECIFIC WAY TO TAKE DOWN THE ADHESIONS. THE PROVIDED DOCUMENT STATED THAT WITH MINIMAL CAUTERY THE ADHESIONS WERE TAKEN DOWN IN ORDER FOR THE ROBOTIC PORTS TO ALL BE PLACED, EXCEPT FOR THE ONE ON THE LEFT HAND SIDE. THE SURGEON WAS ABLE TO PERFORM LYSIS OF THE ADHESIONS TO GAIN ADEQUATE EXPOSURE OF THE PROSTATE GLAND. THE LEFT SIDED ADHESIONS WERE NOT FULLY TAKEN DOWN. THE REMAINDER OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DIFFICULTIES. THE OPERATIVE NOTE INDICATED THAT THE PATIENT'S BOWEL WAS CAREFULLY INSPECTED FOR INJURY AND THERE WAS ONE AREA OF PERFORATION NOTED IN THE COLON AREA, WHICH WAS CLOSED WITH SUTURES. THE ANASTOMOSIS WAS TESTED FOR WATER TIGHTNESS AND THERE WERE NO COMPLICATIONS NOTED. THE PATIENT MEDICAL RECORDS INDICATE THAT ON (B)(6) 2011, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF WORSENING NAUSEA AND VOMITING. A CHEST X-RAY REPORTEDLY REVEALED A SIGNIFICANT AMOUNT OF AIR UNDER HIS DIAPHRAGM. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND NUMEROUS ADHESIONS IN BOTH THE RIGHT AND LEFT LOWER QUADRANTS OF HIS ABDOMEN WERE OBSERVED WHICH REQUIRED ABOUT 30-45 MINUTES FOR LYSIS. DURING THE PROCEDURE, THE PATIENT'S OPERATIVE REPORT INDICATED THAT THE SURGEON DISCOVERED 2 ENTEROTOMIES IN THE SMALL BOWEL THAT WERE FOUND IN THE LEFT LOWER QUADRANT WITH ABSCESS ACTIVITY. THE SMALL BOWEL WAS RESECTED AND THE ANASTOMOSIS WAS STAPLED. DURING THE PROCEDURE, THE PATIENT'S BLADDER WAS NOTED TO BE ADHERED TO THE BOWEL AND THIS WAS TAKEN DOWN. AT THE CONCLUSION OF THE PROCEDURE, UROLOGY SERVICE CAME INTO THE OPERATING ROOM TO ASSIST WITH THE INFUSION OF 120 ML OF SALINE INTO THE PATIENT'S FOLEY CATHETER AND BLADDER. NO EVIDENCE OF EXTRAVASATION WAS FOUND AND THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. NO ADDITIONAL DISCHARGE NOTE INFORMATION IS AVAILABLE." }, { "mdr_text_key": "11011945", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. ISI HAS ATTEMPTED TO CONTACT THE SITE 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. THE OPERATIVE NOTES PROVIDED WITH THE LEGAL COMPLAINT DID NOT INDICATE THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI PROSTATECTOMY PROCEDURE. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED DA VINCI SI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUSTAINED INJURIES TO HIS SMALL BOWEL AS A RESULT OF UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S BOWEL INJURIES OCCURRED AND IF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." } ], "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": "" } ] }