{ "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": "I", "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": "2955842-2017-00469", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20170721", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20140613", "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", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20170721", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "511865", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170721", "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": "DA", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/26/2017", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20170721", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss", "Tissue Breakdown", "Blood Loss", "Tissue Breakdown" ] } ], "distributor_city": "", "date_report": "20170628", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6732417", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20170628", "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": "114079217", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 07/26/2017, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE'S DIRECTOR OF RISK MANAGEMENT: THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. THERE WAS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. DURING THE SURGICAL PROCEDURE, THE PATIENT UNDERWENT A CYSTOSCOPY. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DIRECTOR OF RISK MANAGEMENT INDICATED THAT A POST-OPERATIVE TORN VAGINAL CUFF WAS NOT LISTED AS A DIAGNOSIS IN THE OPERATIVE REPORT DATED (B)(6) 2014. THE OPERATIVE REPORT NOTED THAT THE CUFF WAS HEMOSTATIC AFTER STITCHES WERE PLACED. A VAGINAL CUFF REPAIR PROCEDURE WAS PERFORMED ON (B)(6) 2014 FOR A SUPERFICIAL CUFF SEPARATION. PER THE OPERATIVE REPORT DATED (B)(6) 2017, AN UNSPECIFIED SMALL ARTERIAL BLEEDER WAS FOUND TO BE ACTIVE UPON EVALUATION OF THE PATIENT IN THE OPERATING ROOM (OR). ACCORDING TO THE DIRECTOR OF RISK MANAGEMENT, THE BLEEDING WAS CONTROLLED WITH CLOSURE OF SUPERFICIAL SEPARATION WITH FIGURE OF 8 SUTURES USING 3 SINGLE STITCHES 0 VICRYL. THE DIRECTOR OF RISK MANAGEMENT STATED, THE SITE HAS NO INFORMATION TO SUGGEST DAVINCI SURGICAL SYSTEM CAUSED HARM. BASED ON THE ADDITIONAL AND CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED POST-OPERATIVE BLEEDING AND RECEIVED TRANSFUSIONS. IN ADDITION, THE PATIENT CLAIMED THAT HER VAGINAL CUFF TORE POST-OPERATIVELY. ALTHOUGH THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM OCCURRED, THE ROOT CAUSES OF THE PATIENT'S ALLEGED POST-OPERATIVE COMPLICATIONS ARE UNKNOWN." }, { "mdr_text_key": "80697627", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. ISI HAS ATTEMPTED TO CONTACT THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED FROM THE HOSPITAL AS OF THE DATE OF THIS REPORT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED POST-OPERATIVE BLEEDING AND RECEIVED TRANSFUSIONS. IN ADDITION, THE PATIENT CLAIMED THAT HER VAGINAL CUFF TORE POST-OPERATIVELY. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S ALLEGED POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM OCCURRED." }, { "mdr_text_key": "80697628", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT'S VAGINAL CUFF AND AN UNSPECIFIED VEIN ALLEGEDLY TORE OPEN ON POST-OPERATIVE DAY 18. DUE TO ALLEGEDLY LOSING SIGNIFICANT BLOOD, THE PATIENT INDICATED THAT SHE RECEIVED DAILY TRANSFUSIONS FOR SEVEN STRAIGHT DAYS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, THE PATIENT CLAIMED THAT SHE HAS SUFFERED FROM MENTAL HEALTH CHALLENGES. IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5070734 ON 07/14/2017 WITH THE FOLLOWING EVENT DESCRIPTION: STATUTE OF LIMITATIONS ENDS FRIDAY (B)(6) 2017. PLEASE HELP! (B)(6) ATTORNEY (B)(6) HAS BEEN LOOKING ALL OVER THE COUNTRY FOR AN OPEN CLASS ACTION LAWSUIT OR SOMEONE WHO HAS DONE SUFFICIENT RESEARCH ON THE DA VINCI ROBOT TO HELP. I HAD A HYSTERECTOMY USING THE DA VINCI ROBOT ON (B)(6) 2014. ON (B)(6) 2014, THE VAGINAL CUFF TORE OPEN, ALONG WITH A VEIN. I LOST SIGNIFICANT BLOOD. SO MUCH THAT ONE OF THE TRAUMA NURSES AND MY MOTHER HAD ME SIGN A STATEMENT SAYING WHO WOULD GET MY DAUGHTER AND WITNESSED IT. THE NURSE WHO WITNESSED MY SIGNATURE, (B)(6), TOLD ME LATER THAT SHE WAS SHOCKED TO SEE ME ALIVE. IN ALL HER YEARS AS A TRAUMA NURSE, SHE HAD NEVER SEEN ANYTHING LIKE IT. SHE SAID I WAS BIRTHING BABY-SIZED BLOOD CLOTS. AFTER SURGERY, I WAS SENT HOME WITHOUT BLOOD BECAUSE MY BLOOD COUNT DIDN'T REFLECT THE BLOOD LOSS YET. (B)(6), I WAS TOO WEAK TO HOLD MY HEAD UP. WHEN I GOT TO (B)(6) HOSPITAL ER DEPARTMENT, THE TOP NUMBER FOR MY BLOOD PRESSURE WAS IN THE 50'S AND THE BOTTOM NUMBER WAS IN THE 30'S SEVERAL STAFF TRIED FOR HOURS (NOT SURE HOW MANY) TO LOCATE A VEIN TO START AN IV AND COULDN'T. THE PAIN IN MY HEAD WAS EXCRUCIATING - AND THE ER COULD NOT GIVE ME ENOUGH PAIN KILLER IN SHOTS TO GET THE PAIN UNDER CONTROL. I WAS TAKEN TO ULTRASOUND TO LOCATE A VEIN AND INSTALL A PIC LINE TO MY HEART. I HAD TRANSFUSIONS (B)(6) AS AN INPATIENT, THEN CAME BACK DAILY THROUGH THE (B)(6) FOR ADDITIONAL TRANSFUSIONS. SINCE THAT TRAUMATIC EXPERIENCE, I HAVE SUFFERED FROM ADDITIONAL MENTAL HEALTH CHALLENGES, GET CONFUSED EASILY, AND HAVE STRUGGLED TO TAKE CARE OF MYSELF AND MY DAUGHTER. A LITTLE OVER A WEEK AGO, I FOUND OUT I HAVE BRAIN DAMAGE BASED ON RESULTS OF A NEUROPSYCHOLOGICAL EXAM. APPARENTLY, A BRAIN SCAN COULD IDENTIFY WHAT DAMAGE IS FROM EXTERNAL FORCE AND WHAT'S CAUSED BY A NOXIA. REGARDLESS OF WHAT THOSE RESULTS COULD SAY, I HAVE NOT BEEN THE SAME SINCE. MY DAUGHTER NOW SUFFERS FROM PTSD, AS WELL. I WAS HOME ALONE WITH MY DAUGHTER (IN THE COUNTRY) WHEN THE BLOOD STARTED FLOWING. SHE WAS 4 AT THE TIME- AND THOUGHT SHE WAS WATCHING HER MOMMY BLEED TO DEATH. THERE'S MORE. HOPING THIS IS ENOUGH TO GET HELP! CONCOMITANT MEDICAL PRODUCTS (F): RX MEDS: FLUOXETINE, RITALIN, LORAZEPAM, VAGINAL MESH, OTC MEDS: LAVENDER SUPPLEMENTS ON 07/19/2017, ISI CONTACTED THE PATIENT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE WAS COMPLETED WITH NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR ISSUES WITH THE DA VINCI SURGICAL SYSTEM. SHE INDICATED THAT THE SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2014. THE PATIENT INDICATED THAT SHE REVIEWED HER MEDICAL RECORDS AND NOTICED THAT WITH THE DA VINCI-ASSISTED SURGICAL PROCEDURE, AN UNSPECIFIED BLADDER PROCEDURE WAS ALSO PERFORMED. SHE DID NOT HAVE DETAILS REGARDING THE BLADDER PROCEDURE. SHE BELIEVES THAT THE BLADDER PROCEDURE WAS LIKELY PERFORMED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE SINCE SHE WAS ONLY PUT UNDER ONE TIME DURING HER HOSPITALIZATION. ON AN UNSPECIFIED DATE THIS YEAR, 2017, THE PATIENT INDICATED THAT SHE WAS DIAGNOSED AT A DIFFERENT UNSPECIFIED MEDICAL FACILITY WITH BRAIN DAMAGE FROM ANOXIA. SHE DID NOT KNOW THE ROOT CAUSES OF THE ANOXIA OR BRAIN DAMAGE." } ], "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": "08/11/2017" } ] }