{ "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": "2955842-2013-04853", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20101020", "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": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "559688", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "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", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20131031", "sequence_number_treatment": [ "DAV SI SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "83", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Fever", "Hematoma", "Inflammation", "Nausea", "Hernia", "Therapeutic Response, Decreased", "Discomfort", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3441353", "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": "11244374", "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 THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S SIGMOID COLON WAS PERFORATED DURING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "3856981", "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 HYSTERECTOMY AND LYSIS OF ADHESIONS FOR A HISTORY OF DYSFUNCTIONAL UTERINE BLEEDING AND UTERINE FIBROIDS ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE FOLLOW-UP HERNIA REPAIR PROCEDURES. REVIEW OF THE PATIENT'S OP REPORT FOUND NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. UPON INITIAL ENTRY, THE PATIENT HAD MULTIPLE DENSE ADHESIONS OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL WHICH WERE TAKEN DOWN. THE ROUND LIGAMENTS, UTEROOVARIAN LIGAMENTS AND UTERINE ARTERIES WERE IDENTIFIED, CAUTERIZED AND DIVIDED IN A SEQUENTIAL MANNER. THE BLADDER FLAP WAS DEVELOPED, THE CARDINAL AND UTEROSACRAL LIGAMENTS WERE DISSECTED, AND THE CERVIX CIRCUMSCRIBED AT THE LEVEL OF THE V-CARE UTERINE MANIPULATOR. THE UTERUS WAS DELIVERED THROUGH THE VAGINA AND THE VAGINAL CUFF CLOSED WITH VICRYL SUTURE. EXTENSIVE DISSECTION OF REMAINING ADHESIONS WAS DONE WITH EVICEL FIBRIN SEALANT PLACES OVER THE RAW SURFACES, BUT THE RIGHT OVARY WAS LEFT IN SITU AS IT WAS ADHERED OVER THE URETER AND IT WAS FELT TO BE TOO GREAT A RISK TO THE URETER TO DISSECT IT OFF. THE SURGERY WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT PRESENTED WITH NAUSEA, LOWER ABDOMINAL DISCOMFORT AND ELEVATED TEMPERATURE. CT IMAGING SHOWED PNEUMOPERITONEUM, PELVIC INFLAMMATORY CHANGES WITH FLUID COLLECTIONS IN THE PELVIC SIDE WALL AND POSSIBLE PELVIC HEMATOMA. THE PATIENT WAS TAKEN TO THE OR WHERE A SIGMOID COLECTOMY AND COLOSTOMY WAS PERFORMED THROUGH A MIDLINE LAPAROTOMY INCISION FOR A PERFORATED SIGMOID COLON. OF NOTE, THERE WAS SIGNIFICANT INFLAMMATORY CHANGES, AND SUCCUS EMANATING FROM A LOOP OF SIGMOID COLON. THE PERFORATED SECTIONS OF THE SIGMOID WERE STAPLED OFF AND REMOVED AND AN OSTOMY WAS BROUGHT TO THE LEFT ABDOMINAL WALL. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. THE PATHOLOGY ON THE REMOVED SPECIMEN NOTED THE PERFORATIONS TO BE FOCALLY HEMORRHAGIC CONSISTENT WITH DIVERTICULA. ON (B)(6) 2011, THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY AND LYSIS OF ADHESIONS FOR ACUTE CHOLECYSTITIS. ON (B)(6) 2011, THE PATIENT UNDERWENT AN OPEN REVERSAL OF HER COLOSTOMY. AT THE TIME OF SURGERY IT WAS NOTED THAT THE ABDOMEN DID NOT HAVE MUCH IN THE WAY OF ADHESIONS. THE COLON WAS RECONNECTED WITH A SIDE TO SIDE STAPLED ANASTOMOSIS AND THE FACIAL DEFECTS WERE SUTURED CLOSED. ON (B)(6) 2012, THE PATIENT PRESENTED WITH AN INCARCERATED VENTRAL HERNIA IN THE MIDLINE INCISION AND UNDERWENT A REPAIR WITH MESH. ON (B)(6) 2013, PATIENT UNDERWENT A MESHLESS OPEN REPAIR OF THE RECURRENT MIDLINE HERNIA AND A NEWLY DEVELOPED HERNIA AT THE OLD OSTOMY SITE. AT THIS TIME THE RIGHT ADNEXAL MASS WAS REMOVED FROM ATOP THE URETER, AND THE URETER CHECKED FOR FUNCTION AFTER THE PROCEDURE. ON (B)(6) 2013, THE PATIENT'S WOUND SEEMED TO BE HEALING WELL WITH NO RECURRENCE OF HERNIA. ON (B)(6) 2013, A 4CM RECURRENT HERNIA HAD DEVELOPED AT THE TOP OF THE MIDLINE INCISION. CURRENT PLAN IS TO OBSERVE AND REPAIR IF GROWS. NO FURTHER RECORDS WERE AVAILABLE AFTER THIS DATE." } ], "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": "" } ] }