{ "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": "2955842-2013-03152", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111003", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410181", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "33 YR", "patient_sex": "", "patient_weight": "118", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Tissue Damage", "Hernia" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305606", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "3833685", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI OVARIAN CYSTECTOMY PROCEDURE (B)(6) 2011. ON (B)(6) 2011 THE PATIENT RETURNED TO THE HOSPITAL EMERGENCY ROOM COMPLAINING OF SEVERE ABDOMINAL PAIN IN THE PERIUMBILICAL AREA. DURING A CT SCAN IT WAS DISCOVERED THAT THE PATIENT HAD AN INCARCERATED HERNIA. ON (B)(6) 2011, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR THE HERNIA. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE SURGICAL PROCEDURE OF (B)(6) 2011 ALLEGED THAT DURING THE DA VINCI SI OVARIAN CYSTECTOMY PROCEDURE, IT WAS NOTED THAT THE PATIENT SIDE MANIPULATOR ARMS ON THE PATIENT SIDE CART COLLIDED A LOT WHILE DOCKED TO A SINGLE PORT SITE. TO RESOLVE THE ISSUE, THE SURGEON MADE THE DECISION TO CREATE ADDITIONAL PORT SITES TO PERFORM THE PROCEDURE USING MULTIPLE PORTS. THERE WERE NO OTHER SYSTEM ISSUES DOCUMENTED IN THE OP REPORT. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS ON (B)(6) 2011 SHOWED THAT THE PATIENT HAD A MIDLINE VENTRAL HERNIA, JUST SUPERIOR TO THE UMBILICUS. THE HERNIA CONTAINED OMENTAL FAT THAT WAS MILDLY EDEMATOUS. SUBCUTANEOUS EDEMA WAS ALSO NOTED TO BE TRACKING ALONG THE PATIENT LOWER LEFT ANTERIOR ABDOMINAL WALL. NO FOCAL FLUID COLLECTION OR ABSCESS WAS DISCOVERED. A 3 CM CYSTIC STRUCTURE WAS ALSO NOTED IN THE RIGHT ADNEXA, POSSIBLY REPRESENTING AN OVARIAN CYST. DURING THE SURGICAL PROCEDURE TO REPAIR THE PATIENT'S HERNIA ON (B)(6) 2011, THE SURGEON IDENTIFIED A LARGE DEFECT TO THE LEFT OF THE UMBILICUS AS WELL AS ABOVE THE UMBILICUS WHICH CONTAINED INCARCERATED TISSUE. THE TISSUE WAS STUCK AND ADHERENT AND WAS COMING OUT THROUGH THE DEFECT. THE INCARCERATED TISSUE CONSISTED OF OMENTUS AND THERE WAS SOME SEMBLANCE OF A SAC FORMING IN THIS AREA. EXAMINATION OF THE OMENTUM SHOWED STRANGULATED OMENTUM IN SEVERAL AREAS. THE STRANGULATED TISSUE WAS TRANSECTED UNTIL VIABLE OMENTU REMAINED. A SEPARATE UMBILICAL HERNIA DEFECT MEASURING 1 CM IN SIZE WAS DISCOVERED. THERE WERE OTHER SMALL DEFECTS ALSO FOUND IN THE ANTERIOR RECTUS SHEATH AND THE SURGEON STATED THAT PERHAPS THESE OCCURRED DURING REPLACEMENT OF A NEEDLE OR TROCAR. THE PERIPHERAL DEFECTS AND HERNIA WERE REPAIRED WITH SUTURES. DUE TO THE PATIENT'S OBESITY, HER INCISIONAL HERNIA WAS REINFORCED WITH MESH TO REDUCE THE RISK OF RECURRENCE. THE PATIENT'S UMBILICUS WAS EXCISED AND MESH WAS PLACED TO COVER THE ENTIRE AFFECTED AREA. AN UMBILECTOMY WAS ALSO PERFORMED, AS THE BLOOD SUPPLY TO THE PATIENT'S UMBILICUS WAS SUSPECTED. THE SURGICAL PROCEDURE WAS COMPLETED. BASED ON THE INFORMATION IN THE OP REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL AND DID NOT EXPERIENCE ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE PATIENT'S MEDICAL RECORDS INDICATED THAT DURING A POST-SURGICAL FOLLOW-UP EXAMINATION ON (B)(6) 2011 THE PATIENT WAS FOUND TO BE DOING WELL AND HAS NOT EXPERIENCED ANY COMPLICATIONS OR INFECTIONS." }, { "mdr_text_key": "11063994", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. 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. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI OVARIAN CYST 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": "" } ] }