{ "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": "2955842-2013-03170", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "", "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": "410047", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI 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": "", "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": [ "Overheating of Device" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Burn(s)", "Fistula", "Incontinence", "Itching Sensation", "Scarring", "Vaginal Mucosa Damage", "Hernia" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305772", "removal_correction_number": "", "number_devices_in_event": "", "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": "3709559", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE IN (B)(6) 2008. THE DOCUMENTATION PROVIDED ALLEGED THAT THE PATIENT'S VAGINAL WALL WAS BURNED DURING HER HYSTERECTOMY AND SHE SUFFERED A RECTAL-VAGINAL FISTULA RESULTING IN A COLOSTOMY, MULTIPLE CT SCANS, SEVERAL OUTPATIENT SURGERIES AND PROCEDURES AND 2 ADDITIONAL MAJOR SURGERIES WITH HOSPITAL STAYS. THE DOCUMENTATION PROVIDED STATES THAT THE PATIENT HAD A FIBROID GROWTH ON HER UTERUS FOR MANY YEARS AND HAD FOR SOME TIME BEEN EXPERIENCING INCREASING ABDOMINAL PAIN. THE PATIENT CLAIMED THAT AS A RESULT OF THE BURN TO HER VAGINAL WALL, SHE DEVELOPED A VAGINAL-RECTAL FISTULA AND STOOL WAS COMING OUT OF HER VAGINA. THE DOCUMENTATION STATES THAT THE PATIENT HAD A COLOSTOMY PERFORMED ON AN UNSPECIFIED DATE FOLLOWED BY AN ATTEMPT TO REPAIR THE FISTULA. IN ADDITION, THE PATIENT REPORTEDLY DEVELOPED ABDOMINAL PAIN AND BLOATING FROM THE PROCEDURES AND MEDICATIONS, WHICH CAUSED HER TO SPEND A DAY IN THE ER. THIS SURGERY WAS PERFORMED IN (B)(6) 2008. ACCORDING TO THE ALLEGATIONS, DURING HER STAY IN THE ER, CT SCANS AND AN OUTPATIENT COLONOSCOPY PROCEDURE WERE PERFORMED TO DETERMINE IF THE FISTULA WAS HEALED ENOUGH TO BE REVERSED. THE DOCUMENTATION STATED THAT WHEN THE REVERSAL WAS DONE, THE SURGEON DISCOVERED PART OF THE PATIENT'S BOWEL NEEDED TO BE RESECTED. THE DATE OF THE BOWEL RESECTION PROCEDURE WAS NOT PROVIDED. ON AN UNSPECIFIED DATE A FEW MONTHS LATER, THE PATIENT DEVELOPED AN INCISIONAL HERNIA AT THE SITE OF THE COLOSTOMY AND WENT IN FOR SURGERY AGAIN ON (B)(6) 2008. THE DOCUMENTATION ALSO STATES THAT THE PATIENT HAS SCARS THAT ARE IRRITATING AND SHE HAS ABDOMINAL PAIN ON THE LEFT SIDE THAT REQUIRES MEDICATION TO MAKE IT BEARABLE. THE PATIENT'S PHYSICIAN INFORMED HER THAT THE PAIN IS FROM ADHESIONS FROM THE MULTIPLE SURGERIES. NO ADDITIONAL PATIENT RECOVERY INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11013092", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, AND IN ABSENCE OF MEDICAL / CLINICAL OPERATIVE, DISCHARGE AND POST OPERATIVE DOCUMENTATION, 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. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BURN TO HER VAGINAL WALL DURING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S INJURY OCCURRED AND IF THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY." } ], "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": "" } ] }