{ "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": "2955842-2013-03309", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130830", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111117", "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": "20130830", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "429517", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130830", "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, A60.P8", "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": [ "Material Protrusion/Extrusion" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20130830", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "40 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Purulent Discharge", "Pain", "Perforation", "Abnormal Vaginal Discharge", "Peritonitis", "Organ Dehiscence" ] } ], "distributor_city": "", "date_report": "20130812", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3318273", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130812", "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": "3704287", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DEMAND LETTER AND MEDICAL RECORDS INVOLVING A PATIENT WHO REPORTEDLY SUFFERED FROM POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS PELVIC PAIN, ABNORMAL UTERINE BLEEDING, AND DYSPAREUNIA. THE PATIENT'S CERVIX AND UTERUS WERE REMOVED WITHOUT COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ACCORDING TO THE DEMAND LETTER, THE PATIENT STARTED TO HAVE PROBLEMS WITH PELVIC PAIN AND VAGINAL DRAINAGE AND SHE STATED SHE FELT AS IF SOMETHING CAME LOOSE FROM MY BODY ON AN UNSPECIFIED DATE. ON (B)(6) 2012, APPROXIMATELY 4 MONTHS AFTER THE DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A VAGINAL CUFF PERFORATION, CUFF DEHISCENCE, AND MILD PERITONITIS. THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY AND LAPAROSCOPIC REPAIR OF THE CUFF PERFORATION AND CUFF DEHISCENCE. PER THE (B)(6) 2012 OPERATIVE REPORT, THERE WAS A PIECE OF OMENTUM THAT WAS PROTRUDING THROUGH THE VAGINAL PERFORATION. THERE WAS ALSO SOME PURULENT DISCHARGE FOUND IN THE POSTERIOR CUL-DE-SAC CONSISTENT WITH MILD PERITONITIS. THE PATIENT'S ABDOMEN WAS WELL IRRIGATED TO CLEAN THE LEAKAGE DUE TO THE PERITONITIS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. APPROXIMATELY 2 WEEKS AFTER HER SURGERY ((B)(6) 2012), THE PATIENT CONTACTED HER DOCTOR WITH REPORTED HEAVINESS IN HER VAGINA AND REQUESTED A REFILL ON HER PAIN MEDICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ISI ABOUT HER CURRENT STATUS." }, { "mdr_text_key": "11233515", "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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2011 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY 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": "" } ] }