{ "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": "2955842-2013-04329", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20131011", "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": "20131011", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "522581", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131011", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "IL", "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": "20131011", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "43", "patient_sex": "", "patient_weight": "99", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Perforation", "Peritonitis" ] } ], "distributor_city": "", "date_report": "20130911", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3406004", "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": "20860353", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED AN OPERATIVE REPORT AND A LEGAL DOCUMENT FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. DURING THE DA VINCI HYSTERECTOMY PROCEDURE A NEEDLE FELL IN PATIENT. PER THE OPERATIVE REPORT THE SURGEON STATED THAT THE NEEDLE WAS LOST UPON TRYING TO REMOVE IT FROM THE PORT. ATTEMPTS WERE MADE TO FIND THE NEEDLE AND AN X-RAY AND FLUOROSCOPY WERE PERFORMED AND THE NEEDLE WAS LOCATED IN THE RIGHT UPPER QUADRANT AND WAS REMOVED THROUGH THE TROCAR SLEEVE INTACT. NO FURTHER COMPLICATIONS WERE NOTED, AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM POST- PROCEDURE. THIS LEGAL DOCUMENT ALLEGES THAT THE PATIENT'S BOWL MAY HAVE BEEN INJURED BY UNINTENDED AND UNKNOWN RELEASE OF MONOPOLAR ENERGY FROM THE CAUTERY DEVICE OF THE ROBOT. ACCORDING TO THE LEGAL DOCUMENT, APPROXIMATELY AFTER 8 DAYS OF WORSENING SYMPTOMS, THE PATIENT BECAME SEPTIC. ON (B)(6) 2011, A LAPAROTOMY WITH WASHOUT OF ABDOMEN AND SMALL BOWEL RESECTION WAS PERFORMED. IT WAS ALLEGED IN THE LEGAL DOCUMENT THAT DURING THIS PROCEDURE, THE PATIENT WAS FOUND TO HAVE PERITONITIS, AND PERFORATION OF THE SMALL INTESTINE. ON (B)(6) 2011, THE PATIENT RETURNED FROM THE ICU TO THE OR AGAIN. THE SURGEON PERFORMED ANOTHER EXPLORATORY LAPAROTOMY WITH WASHOUT OF THE ABDOMEN, APPENDECTOMY AND RETENTION SUTURE CLOSURE OF THE ABDOMEN. NO FURTHER CLINICAL INFORMATION HAS BEEN PROVIDED." }, { "mdr_text_key": "21137738", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL 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. INTUITIVE SURGICAL INC. (ISI) HAS REVIEWED THE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2011 AND NO MALFUNCTIONS WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED POST -SURGICAL COMPLICATIONS." } ], "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": "" } ] }