{ "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": "2955842-2013-04382", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131011", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110811", "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": "522431", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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 S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "54 YR", "patient_sex": "", "patient_weight": "95", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Laceration(s)", "Necrosis", "Pain", "Discomfort", "Fluid Discharge", "Constipation" ] } ], "distributor_city": "", "date_report": "20130911", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3407052", "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": "3886093", "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 THAT UNDERWENT A DA VINCI S SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND SACROCOLPOPEXY ON (B)(6) 2011. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT ELECTED TO HAVE AN ABDOMINAL HYSTERECTOMY AFTER DEVELOPING UTEROVAGINAL PROLAPSE DURING (B)(6) 2009. THE OPERATIVE REPORT FOR THE DA VINCI S SURGICAL PROCEDURE WAS NOT PROVIDED FOR REVIEW. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. SHE WAS DISCHARGED ON AN UNSPECIFIED ANTIBIOTIC TO BE TAKEN TWICE A DAY. ON (B)(6) 2011, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF FEVER, CONSTIPATION, AND PELVIC PAIN, PRESSURE, AND DISCHARGE. CT SCANS OF THE PATIENT'S ABDOMEN PERFORMED ON (B)(6) 2011 REVEALED A PELVIC ABSCESS NEXT TO THE VAGINAL CUFF. THE PATIENT WAS TREATED CONSERVATIVELY WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE. ON (B)(6) 2011, THE PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE IN ADDITION TO EXPLORATORY LAPAROTOMY WITH REMOVAL OF THE SACROCOLPOPEXY MESH. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON DID NOT FIND ANY EVIDENCE OF AN INJURY TO THE BOWEL OR VASCULAR STRUCTURES. THE SACROCOLPOPEXY MESH WAS REMOVED INTACT. HOWEVER, IN THE POSTERIOR CUL DE SAC, THE PATIENT WAS NOTED TO HAVE A COLLECTION OF FIBRINOUS/NECROTIC TISSUE AND MINIMAL INFECTED FLUID WHICH HAD CREATED A RECTAL MUSCULARIS TEAR. THE SURGEON REPAIRED THE RECTAL MUSCULARIS TEAR WITH SUTURES AND THEN PERFORMED A PELVIC WASHOUT. TOWARDS THE CONCLUSION OF THE SURGICAL PROCEDURE, A CYSTOSCOPY WAS PERFORMED AND NO EVIDENCE OF A BLADDER PERFORATION WAS FOUND. THE PATIENT WAS THEN AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011 AND IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE FROM THE HOSPITAL ON (B)(6) 2011." }, { "mdr_text_key": "11118020", "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 COMPLICATIONS EXPERIENCED BY THE PATIENT. 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 DEVELOPED A PELVIC ABSCESS AND REQUIRED ADDITIONAL MEDICAL INTERVENTION AFTER UNDERGOING A DA VINCI 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": "" } ] }