{ "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": "2955842-2013-04916", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131103", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130812", "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": "565502", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131103", "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 A6.0P8", "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": "20250822", "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": "20131103", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "132", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Adhesion(s)", "Hemorrhage/Blood Loss/Bleeding", "Hypovolemic Shock", "Inflammation", "Nausea", "Vasculitis", "Sepsis", "Vomiting", "Peritonitis", "Injury", "Bowel Perforation", "No Code Available" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444766", "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": "3788694", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY FOR MALIGNANT NEOPLASM OF THE PROSTATE ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND HIS SUBSEQUENT LAPAROTOMIES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGERY WAS NOTABLE FOR SIGNIFICANT ADHESIONS FROM A PRIOR EXPLORATORY LAPAROTOMY WHICH REQUIRED EXTENSIVE LYSIS OF ADHESIONS PRIOR TO THE DOCKING OF THE ROBOT. THE PROSTATECTOMY PROCEEDED IN A STEPWISE MANNER WITH DROPPING OF THE BLADDER, DISSECTION OF THE ENDOPELVIC FASCIA WITH SHARP DISSECTION, BLUNT DISSECTION OF THE LEVATOR FIBERS, AND INCISION INTO THE JUNCTION BETWEEN THE BLADDER NECK AND THE PROSTATE. THE SURGEON PERFORMED TRANSECTION OF THE SEMINAL VESICLES AND VAS DEFERENCE AND SHARP DIVISION OF THE REMAINING LATERAL ATTACHMENTS. THE POSTERIOR DIVISION BETWEEN THE PROSTATE AND THE RECTUM WAS PERFORMED WITHOUT INJURY TO THE RECTUM. THE DORSAL VENOUS COMPLEX, URETHRA AND REMAINING LATERAL AND POSTERIOR ATTACHMENTS WERE DIVIDED. THE SPECIMEN THEN REMOVED, AND THE URETHROVESICAL ANASTOMOSIS PERFORMED, AND THE SURGERY COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2013 PATIENT PRESENTED TO ED WITH SEVERE RIGHT LOWER QUADRANT ABDOMINAL PAIN, NAUSEA AND VOMITING WITH GREEN EMESIS. PATIENT ADMITTED FOR SUSPECTED SEPSIS AND LEAK WITH ACUTE PERITONITIS, RENAL INSUFFICIENCY AND METABOLIC ACIDOSIS. PATIENT WAS TAKEN EMERGENTLY TO THE O.R. WHERE AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION WAS PERFORMED FOR SMALL BOWEL PERFORATION. UPON ENTRY, THE ABDOMEN WAS GROSSLY CONTAMINATED WITH SUCCUS, AND HAD FILMY ADHESIONS. THE ADHESIONS WERE BLUNTLY DISSECTED, AND A BOWEL PERFORATION OF TWO THIRDS THE CIRCUMFERENCE OF THE SMALL BOWEL WAS FOUND IN THE DISTAL JEJUNUM. THE AREA WAS RESECTED WITH A GASTROINTESTINAL ANASTOMOSIS (GIA). THE PATIENT'S CONDITION PRECLUDED REANASTOMOSIS AND HE WAS TAKEN TO THE MEDICAL SURGICAL INTENSIVE CARE UNIT (MSICU) IN GUARDED CONDITION WITH OPEN ABDOMEN FOR STABILIZATION. ON (B)(6) 2013 PATIENT WAS RETURNED TO THE O.R. FOR ATTEMPTED REANASTOMOSIS AND CLOSURE OF THE ABDOMEN. A PORTION OF THE BOWEL WITH CIRCUMFERENTIAL ADHESIONS WAS REMOVED, AND THE ABDOMEN SWEPT CLEAR OF FILMY ADHESIONS. DESPITE THE GENERAL INFLAMMATION, THE BOWEL APPEARED AMENABLE TO REANASTOMOSIS WHICH WAS PERFORMED IN A SIDE TO SIDE MANNER WITH A GIA STAPLER. THE ABDOMEN WAS IRRIGATED, THE WOUND EDGES DEBRIDED AND TEMPORARILY CLOSED OVER A NEGATIVE PRESSURE GRANUFOAM DRESSING. ON (B)(6) 2013 THE PATIENT WAS RETURNED TO THE O.R. TO CLOSE THE ABDOMEN WHICH WAS PERFORMED WITH VICRYL SUTURE AND NYLON RETENTION SUTURES. PATIENT WAS RETURNED TO MSICU INTUBATED IN STABLE CONDITION WITH VACUUM DRESSING OVER WOUND. ON (B)(6) 2013 PATIENT UNDERWENT A LAPAROTOMY FOR FAILURE OF THE JEJUNOJEJUNOSTOMY AT THE STAPLE LINE. THE JEJUNAL SITES WERE STAPLED OFF, THE FAILED ANASTOMOSIS REMOVED, AND THE ABDOMEN PACKED FOR LATER WASHOUT. THE CEPHALIC VEIN WAS THEN RESECTED FROM THE LEFT ARM FOR ACUTE THROMBOPHLEBITIS. ON (B)(6) 2013 PATIENT WAS RETURNED TO THE O.R. FOR REANASTOMOSIS OF THE JEJUNUM WHICH WAS HAND SEWN. THE ABDOMINAL WOUND WAS DEBRIDED AND THE SKIN CLOSED WITH THE PLAN TO BRING HIM BACK TO THE O.R. FOR FACIAL CLOSURE IN A FEW DAYS. LATER THAT DAY THE PATIENT RETURNED TO THE O.R. EMERGENTLY FOR ACUTE BLOOD LOSS AND HEMORRHAGIC SHOCK SECONDARY TO A CAPSULAR TEAR OF THE SPLEEN. HE RECEIVED AN EMERGENT SPLENECTOMY AND 3 UNITS OF PACKED RED BLOOD, 2 OF FRESH FROZEN PLASMA (FFP). ON (B)(6) 2013 PATIENT RETURNED TO THE O.R. FOR AN ABDOMINAL WASHOUT. NO ADDITIONAL RECORDS WERE PROVIDED AFTER THE DATE OF SURGERY." }, { "mdr_text_key": "11371602", "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 FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL 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": "" } ] }