{ "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": "2955842-2013-04973", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120503", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562188", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "", "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": [ "Crack" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20131101", "sequence_number_treatment": [ "DA VINCI S SURG SYS INSTRUMENTS, ACCESSORIES & ES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "60 YR", "patient_sex": "", "patient_weight": "142", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bruise/Contusion", "Nausea", "Vomiting", "Peritonitis", "Injury", "Burn, Thermal", "Abdominal Distention" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444360", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "3900229", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S PROSTECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION ON (B)(6) 2013 FOR PROSTATE CANCER. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORTS FOR THE PRIMARY SURGERY AND THE EXPLORATORY LAPAROTOMY AND THE DISCHARGE SUMMARY. AFTER STANDARD ENTRY, THE ABDOMEN WAS INSPECTED FOR TROCAR OR VERESS NEEDLE INJURY WITH NO PATHOLOGY OBSERVED. ABUNDANT LOOPS OF SMALL BOWEL WERE FOUND SLIDING INTO THE PELVIS WHICH WERE RETRACTED. THE SURGEON PERFORMED A STANDARD PROSTATECTOMY WITH DISSECTION AND TRANSECTION OF SEMINAL VESICLES AND VAS DEFERENS. IT WAS NOTED THAT DURING THE DISSECTION LOOPS OF BOWEL KEPT SLIDING INTO THE PELVIS REQUIRING REPOSITIONING OF THE PROGRASP TO IMPROVE RETRACTION. THE PELVIC LYMPHNODE DISSECTION WAS COMPLETED TO THE LEVEL OF THE OBTURATOR NERVES. DURING THE LYMPHATIC DISSECTION THERE WAS INDICATION OF AN UNINTENTIONAL SUPERFICIAL CAUTERY INJURY TO THE EXTERNAL ILIAC VEIN BECAUSE OF A CRACK IN THE INSULATION SHEATH OF THE RIGHT ROBOTIC INSTRUMENT WHICH IS INTERPRETED TO BE A MONOPOLAR CURVED SHEARS. THE SHEATH COVER WAS REPLACED, AND THERE WERE NO REPORTED COMPLICATIONS INVOLVING THE INVOLVED STRUCTURE. IN THE REMAINDER OF THE PROCEDURE THERE WAS NO REPORT OF ANY MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR OTHER ACCESSORIES. THE PROSTATIC DISSECTION WAS COMPLETED TO THE APEX, THE BLADDER NECK TRANSECTED WITH MONOPOLAR AND BIPOLAR CAUTERY, AND THE NEUROVASCULAR BUNDLES DISSECTED OFF WITH COLD SCISSORS AND BIPOLAR CAUTERY FOR BLEEDERS. THE DORSAL VENOUS COMPLEX AND URETHRA WERE TRANSECTED SHARPLY, AND THE URETHROVESICAL ANASTOMOSIS PERFORMED. THE SPECIMEN REMOVED, ABDOMEN INSPECTED FOR SIGNS OF INJURY, AND THE PORTS CLOSED. ON (B)(6) 2013 (POST OP DAY 2), PATIENT EXHIBITED WORSENING ABDOMINAL DISTENTION AND NAUSEA AND VOMITING AND AN ABDOMINAL EXAM CONSISTENT WITH PERITONITIS. HE WAS TAKEN TO THE OPERATING ROOM FOR EXPLORATORY LAPAROTOMY WITH SUSPICION OF BOWEL INJURY. THERE WERE AREAS OF BRUISED SMALL BOWEL NOTED AND A PARTIAL THICKNESS THERMAL INJURY ON THE ILEUM IDENTIFIED. IT WAS NOTED THAT THIS WAS NOT FULL-THICKNESS, AND THE AREA WAS INVERTED WITH A LEMBERT STITCH. HE WAS TRANSFERRED TO THE TICU POSTOPERATIVELY. HIS POSTOPERATIVE COURSE WAS COMPLICATED BY PROLONGED ILEUS AND DIFFICULTY WITH BLOOD PRESSURE CONTROL. HE WAS DISCHARGED ON (B)(6) 2013 IN STABLE CONDITION WITH NORMAL BOWEL FUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "11244892", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THERMAL INJURIES SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A THERMAL INJURY TO THE ILEUS. THE PATIENT ALSO SUSTAINED A SUPERFICIAL CAUTERY INJURY TO THE EXTERNAL ILIAC VEIN. MEDWATCH REPORT 2955842-2013-04953 WAS SUBMITTED REGARDING THE THERMAL INJURY TO THE EXTERNAL ILIAC VEIN." } ], "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": "" } ] }