{ "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": "2955842-2012-01043", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20121121", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20120627", "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": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20121121", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121121", "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": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20121121", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Unspecified Infection", "Swelling", "Injury" ] } ], "distributor_city": "", "date_report": "20121024", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2842860", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121024", "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": "3003287", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI S HYSTERECTOMY PROCEDURE WAS SUBMITTED TO INTUITIVE SURGICAL ON (B)(6) 2012 THROUGH THE (B)(4) WEBSITE: MY EXPERIENCE WAS HORRIFIC. I HAD A RADICAL HYSTERECTOMY FOR CERVICAL CANCER. MY FAMILY WAS UNSUPPORTIVE AS WELL. I WOULD NOT EVER RECOMMEND DA VINCI. AND I CERTAINLY WOULD NOT RECOMMEND THE HOSPITAL WHERE MY SURGERY WAS PERFORMED. I WAS NOT PROVIDED ANY INFORMATION ABOUT WHAT TO EXPECT. THE ADMITTING NURSES DID NOT COMPLETE ALL PAPERWORK FOR PROPER ADMITTANCE. I WAS GIVEN TOO MUCH ANESTHESIA AND NOT FULLY RECOVERED IN THE RECOVERY ROOM. WHILE STILL GROGGY FROM SURGERY I WAS ASKED ALL KINDS OF MEDICAL QUESTIONS AND DIDN'T KNOW WHAT WAS GOING ON, WHICH I THINK IS JUST RIDICULOUS OF A MEDICAL STAFF. I WAS IN ICU FOR 1 DAY AND THERE WAS A TOTAL LACK OF PRIVACY FOR URINATING ONCE THE CATHETER WAS REMOVED. AT 10 WEEKS POST SURGERY, I HAD TO HAVE SURGERY AGAIN DUE TO VAGINAL CUFF DEHISCENCE. MY RECOVERY TIME WAS DOUBLE - MY HOSPITAL BILLS WERE MORE THAN DOUBLE. THE VAGINAL CUFF DEHISCENCE WAS VERY SCARY. I WAS A GREAT AMOUNT OF PAIN FOR 6 DAYS PRIOR TO THE SECOND SURGERY. THE RECOVERY TIMES FOR BOTH SURGERIES WERE MUCH LONGER THAN ADVERTISED ON THE INTERNET. I THINK THE NURSING STAFFS NEED TO DO A BETTER JOB OF SETTING EXPECTATIONS PRIOR TO SURGERY AND FOLLOWING UP WITH PATIENTS ONCE THEY LEAVE THE HOSPITAL. I HAVE 5 - 1 +LONG SCARES FROM THE INCISIONS. ONE INCISION BECAME INFECTED WITH STAPH. THE MOST PAINFUL WAS THE INCISION THAT WENT THRU MUSCLE. ALSO THERE WAS A GREAT DEAL OF PAIN IN MY NECK FROM THE ANESTHESIA, AFTER THE FIRST SURGERY. SINCE THE SECOND SURGERY TO REPAIR THE FIRST SURGERY, I HAVE HAD A LOT OF SWELLING IN MY ABDOMEN. I HAVE LOST OVER 20 POUNDS - YOU CAN'T TELL BECAUSE OF THE SWELLING." }, { "mdr_text_key": "10342595", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, THE CONSOLE SURGEON PROVIDED ADDITIONAL DETAILS ON THE EVENT. THE SURGEON INFORMED THAT THERE WAS NO MALFUNCTION OF DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES. THE SURGEON INDICATED THAT THE FIRST SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. THE SURGEON INDICATED THAT THE CAUSE OF THE PATIENT DEHISCENCE AFTER THE SURGERY WAS THE RESULT OF HAVING VAGINAL INTERCOURSE 4.5 WEEKS AFTER THE SURGERY. HE HAD INSTRUCTED THE PATIENT TO ABSTAIN FROM INTERCOURSE FOR A PERIOD OF 8 WEEKS, HOWEVER THIS PATIENT DID NOT FOLLOW THESE GUIDELINES. DR. BARNES INDICATED THIS WAS THE CAUSE OF THE DEHISCENCE. A SECOND SURGERY WAS PROVIDED TO MITIGATE THE VAGINAL DEHISCENCE AND WAS ALSO COMPLETED SUCCESSFULLY WITHOUT COMPLICATIONS. THE PATIENT IS CURRENTLY DOING WELL." }, { "mdr_text_key": "10343906", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "NO ALLEGATIONS OF DEFICIENY HAVE BEEN MADE AGAINST DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES. SYSTEM LOGS FOR THE DA VINCI SYSTEM WERE PULLED FOR THE DATE OF SURGERY. A REVIEW OF SYSTEM LOGS SHOWED NO ERRORS OCCURED ON THE DATE OF SURGERY. THE ROOT CAUSE OF THE ADVERSE EVENTS OF THIS CASE CANNOT BE DETERMINED. ATTEMPTS WILL BE MADE TO GAIN INFORMATION FROM THE ACCOUNT AND IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA." } ], "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": "11/27/2012" } ] }