{ "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": "2955842-2013-03141", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120912", "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": "409806", "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 A6.0P6", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250811", "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", " L", " R" ], "patient_age": "45 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Abdominal Pain", "Abscess", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Inflammation", "Urinary Tract Infection", "Abnormal Vaginal Discharge", "Constipation" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305535", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "3592488", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR UTERINE FIBROIDS, MENORRHAGIA AND ANEMIA. ONE WEEK PRIOR TO THE DA VINCI SURGICAL PROCEDURE ((B)(6) 2012), THE PATIENT WENT TO THE EMERGENCY ROOM (ER) WITH COMPLAINTS OF GENERALIZED WEAKNESS, DIZZINESS, AND NAUSEA. FOR ONE WEEK PRIOR TO THE ER VISIT, SHE HAD HEAVY PERIOD AND PASSED SOME CLOTS. THE PATIENT'S POTASSIUM AND HEMOGLOBIN LEVELS WERE LOW. SHE RECEIVED A BLOOD TRANSFUSION AND HER REPEAT HEMOGLOBIN WAS 12 AND HER POTASSIUM WAS NORMAL. SHE WAS DIAGNOSED WITH ACUTE BLOOD LOSS ANEMIA, SYMPTOMATIC SECONDARY TO MENORRHAGIA AND HYPOKALEMIA. THE PATIENT'S CONDITION WAS OVERALL STABLE AND WAS SENT HOME THE SAME DAY. ON (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A MARKEDLY LARGE UTERUS (16-WEEK UTERUS WITH MULTIPLE UTERINE FIBROIDS) ALONG WITH DENSE PELVIC ADHESIONS FROM THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL. THE ADHESIONS WERE LYSED WITH MONOPOLAR SCISSORS AND PK INSTRUMENT WITHOUT COMPLICATION, TAKING ABOUT 10 MINUTES TO COMPLETE. FOLLOWING THE HYSTERECTOMY, NO LACERATIONS WERE FOUND IN THE VAGINA AND THE VAGINAL CUFF WAS SUTURED WITH 2 LAYERS OF RUNNING SUTURE. GOOD HEMOSTASIS AND VAGINAL CUFF CLOSURE WERE BOTH NOTED AT THE END OF THE PROCEDURE. ACCORDING TO THE POST-OPERATIVE REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL, HAD NO COMPLICATIONS, AND SHE WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THREE DAYS LATER AFTER THE DA VINCI PROCEDURE ((B)(6) 2012), THE PATIENT WENT TO AN EMERGENCY ROOM (ER) AT ANOTHER HOSPITAL COMPLAINING OF ABDOMINAL PAIN AND NOTING THAT SHE HAD NOT HAD A BOWEL MOVEMENT FOR 7-8 DAYS. SHE REPORTED SHE HAD BEEN DISCHARGED HOME FOLLOWING THE HYSTERECTOMY WITH A HEMOGLOBIN OF 7.7, AND IN THE ER, THE PATIENT WAS ALSO NOTED TO HAVE LEUKOCYTOSIS (WBC 23000). SHE WAS ADMITTED TO THE HOSPITAL, GIVEN SOAPSUDS ENEMAS FOR CONSTIPATION, TRANSFUSED WITH 3 UNITS OF BLOOD FOR HER LOW HEMOGLOBIN AND STARTED ON ANTIBIOTICS FOR A URINARY TRACT INFECTION. HER ABDOMINAL PAIN RESOLVED AND SHE WAS DISCHARGED HOME ON (B)(6) 2012. TEN DAYS AFTER THE DA VINCI PROCEDURE ((B)(6) 2012), THE PATIENT WAS TRANSPORTED VIA EMERGENCY MEDICAL SERVICES (EMS) TO THE SAME ER WITH COMPLAINTS OF HEAVY VAGINAL BLEEDING AND A PROGRESSIVELY WORSENING FOUL-SMELLING VAGINAL DISCHARGE. A CT SCAN OF THE ABDOMEN AND PELVIS REVEALED EVIDENCE OF A PELVIC ABSCESS AND SHE WAS ADMITTED AND STARTED ON ANTIBIOTICS. ON (B)(6) 2012, A GYNECOLOGIST PERFORMED A DIAGNOSTIC LAPAROSCOPY WITH EVACUATION OF A HEMATOMA AND REPAIR OF VAGINAL CUFF DEHISCENCE. ACCORDING TO THE PATIENT'S OPERATIVE REPORT, THE DOCTOR IDENTIFIED A LOOSENED BLUE VICRYL STITCH IN THE VAGINAL CUFF AS WELL AS COPIOUS AMOUNTS OF BLOOD CLOTS (HEMATOMA) POSTERIOR TO THE CUFF AND INFLAMMATION ANTERIOR TO THE CUFF. THE HEMATOMA WAS EVACUATED AND THE CUFF WAS SURGICALLY CLOSED AND INTACT AT THE END OF SURGERY. THE SURGEON ALSO NOTED THAT THE PATIENT HAD DENSE BOWEL ADHESIONS. THE VAGINAL CUFF WAS NOTED TO BE INTACT AND THERE WAS NO BLEEDING. THE PATIENT TOLERATED THE PROCEDURE WELL. POSTOPERATIVELY, THE PATIENT'S CONDITION QUICKLY IMPROVED AND SHE WAS DISCHARGED HOME ON (B)(6) 2012. ISI REVIEWED THE POST-OPERATIVE REPORT AND DID NOT FIND ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY." }, { "mdr_text_key": "11067695", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) 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 DOCUMENTATION PROVIDED DOES 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) 2012 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 SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "24206465", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON OCTOBER 4, 2013 INTUITIVE SURGICAL RECEIVED ADDITIONAL INFORMATION AS PART OF A LEGAL DISPUTE REGARDING A PATIENT THAT UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY FOR UTERINE FIBROIDS, MENORRHAGIA AND ANEMIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. THE ONLY INFORMATION IS AN ALLEGATION FROM AN ATTORNEY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. THE ATTORNEY ALLEGATION IS AS FOLLOWS: AT THE TIME OF THE PATIENT'S SURGERY, SHE WAS NOTED AS HAVING AN ENLARGED UTERUS WITH MULTIPLE UTERINE FIBROIDS. SHE HAD MONOPOLAR SCISSORS USED DURING HER CASE, INCLUDING THE USE OF CAUTERY TO TRANSECT THE CERVIX DURING THE COLPOTOMY. THERE WAS NO INDICATION OF ANY SURGICAL COMPLICATION. THE VAGINAL CUFF WAS CLOSED WITH TWO LAYERS OF RUNNING ZERO V-LOC SUTURE. THE SURGEON NOTED A GOOD VAGINAL CUFF CLOSURE IN HIS OPERATIVE DICTATION. FOLLOWING THE SURGERY, MS. (B)(6) HAD ISSUES RELATED TO DIZZINESS AND NAUSEA AND LOWER ABDOMINAL PAIN. SHE SOUGHT TREATMENT AND WAS ADMITTED TO THE HOSPITAL FOR TWO DAYS FROM (B)(6) 2012. THE PATIENT HAD A PERSISTENCE OF NAUSEA AND VOMITING AND ABDOMINAL PAIN AND WAS AGAIN ADMITTED ON (B)(6) 2013. SHE UNDERWENT TESTS, INCLUDING A CT SCAN OF HER ABDOMEN WHICH REVEALED EVIDENCE OF A PELVIC ABSCESS OR A RATHER LARGE SIZE. SHE RECEIVED ANTIBIOTICS AND IV HYDRATION. SUBSEQUENTLY, SHE UNDERWENT A LAPAROTOMY ON (B)(6) 2012 AT WHICH TIME THE SURGEON PERFORMED AN EVACUATION OF A HEMATOMA, REPAIR OF A VAGINAL CUFF DEHISCENCE. ADDITIONALLY, INFLAMMATORY REACTION WAS NOTED THROUGHOUT THE BOWEL. SHE WAS DISCHARGED AFTER ANOTHER THREE DAYS OF HOSPITALIZATION ON (B)(6) 2012. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL 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": "11/02/2013" } ] }