{ "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": "2955842-2013-04371", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131011", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110818", "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": "20131015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "522737", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131011", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "CA", "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": "20131011", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20130911", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3407013", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130911", "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": "3773000", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S SACROCOLPOPEXY AND TRANSOBTURATOR SLING PROCEDURE ON (B)(6) 2011. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF VAGINAL VAULT PROLAPSE AND STRESS URINARY INCONTINENCE. BASED ON THE OPERATIVE REPORT, UPON INSPECTION OF THE ABDOMINAL CAVITY, SOME ADHESIONS WERE NOTED FROM THE SMALL BOWEL TO THE RIGHT PELVIC SIDE WALL. THE DA VINCI SYSTEM WAS DOCKED IN A NORMAL MANNER. THE SURGEON STATED THAT DURING DISSECTION FOR THE UTEROSACRAL SPACE FOR THE PLACEMENT OF THE SUSPENSORY PORTION OF THE Y-MESH, THE SACRAL VEIN WAS INTERRUPTED. THE SURGEON ALSO INDICATED THAT A LARGE AMOUNT OF BLEEDING WAS NOTED AND COULD NOT BE CONTROLLED ROBOTICALLY. DUE TO THE UNCONTROLLED BLEEDING, THE SURGEON ELECTED TO PERFORM EXPLORATORY LAPAROTOMY. THE LAPAROTOMY WAS PERFORMED BY A TRANSVERSE PFANNENSTEIL INCISION THROUGH A PREVIOUS SCAR THAT THE PATIENT HAD. THE INCISION WAS CARRIED THROUGH THE SUBCUTANEOUS TISSUE AND ABDOMINAL FASCIA. DURING THE EXPLORATORY LAPAROTOMY, THE SURGEON FOUND BLEEDING OF THE MIDDLE SACRAL VEIN. THE SURGEON WAS ABLE TO RAPIDLY ACHIEVE HEMOSTASIS AFTER PLACING A SURGICEL PLEDGET OVER THE VEIN AND USING A TACKER TO ATTACH THE SURGICEL TO THE BOWEL. THE SPACE ABOVE THE PLEDGET WAS THEN DISSECTED FREE DOWN TO THE LEVEL OF THE PERIOSTEUM. PROLENE SUTURES WERE THEN PLACED AND THE MESH WAS ATTACHED TO THE PERIOSTEUM. IRRIGATION WAS EMPLOYED AND NO BLEEDING WAS OBSERVED. AFTER ALL LAPAROSCOPIC SPONGES AND HARDWARE WERE REMOVED FROM THE PERITONEAL CAVITY, THE FASCIA, SKIN, AND ROBOTIC INCISION PORTS WERE CLOSED. THE SURGEON THEN PROCEEDED WITH THE TRANSOBTURATOR SLING PROCEDURE. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED POST-OPERATIVELY." }, { "mdr_text_key": "11207808", "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 INTRA-OPERATIVE COMPLICATION 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. 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. 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 PLANNED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED AN INTRA-OPERATIVE COMPLICATION DURING A DA VINCI S SACROCOLPOPEXY PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNCLEAR HOW THE PATIENT'S INJURY OCCURRED." } ], "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": "" } ] }