{ "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": "2955842-2013-03184", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110414", "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": "409674", "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 A6.0P8", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250810", "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": [ "DAV SI SURG SYS. INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "37 YR", "patient_sex": "", "patient_weight": "67", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Edema", "Perforation", "Swelling", "Tachycardia", "Injury", "Elevated Ketones/ Diabetic Ketoacidosis", "Hematuria" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306187", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "3591650", "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 RECEIVED INFORMATION INCLUDING A MEDICAL SUMMARY REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY ON (B)(6) 2011. THE MEDICAL HISTORY SUMMARY STATES THAT THIS PATIENT WAS PLANNED TO UNDERGO A DA VINCI HYSTERECTOMY WITH PLANNED URETERAL STENT PLACEMENT. THE PATIENT HAD EVIDENCE OF NORMAL URETHRA AND BLADDER. THE URETERAL STENTS WERE PLACED SUCCESSFULLY BY THE UROLOGIST AND FOLEY CATHETER WAS PLACED AT THE END OF THE PROCEDURE. THE PATIENT WAS RE-OPENED FOR THE DA VINCI HYSTERECTOMY PROCEDURE. THE MEDICAL HISTORY SUMMARY STATES THAT THE SURGEON WHO WAS PERFORMING THE HYSTERECTOMY PROCEDURE NOTED AN APPROXIMATELY 1-1.5CM OF BLADDER CYSTOTOMY WHILE PERFORMING THE ANTERIOR COLPOTOMY. THE BLADDER CYSTOTOMY WAS REPAIRED WITH NO FURTHER COMPLICATION. THE SURGEON MADE THE DECISION TO PERFORM A SUPRACERVICAL HYSTERECTOMY TO AVOID ANY ADDITIONAL TRAUMA OR INJURY TO THE PATIENT'S BLADDER. THE PATIENT TOLERATED THE PROCEDURE WELL. ACCORDING TO THE MEDICAL HISTORY INFORMATION PROVIDED, PRIOR TO THE DA VINCI SURGICAL SYSTEM BEING DOCKED TO THE PATIENT, THE PATIENT UNDERWENT A PLANNED BLADDER CYSTOSCOPY WITH PLACEMENT OF BILATERAL STENTS, A FOLEY CATHETER WAS PLACED AND A UTERINE MANIPULATOR. TRACTION WAS ENCOUNTER WHILE INSTALLING THE UTERINE MANIPULATOR CAUSING A PERFORATION TO THE PATIENT'S UTERUS. DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTY DISSECTING THE BLADDER AWAY FROM THE CERVIX, AND THE DECISION WAS MADE TO PERFORM A SUPRACERVICAL HYSTERECTOMY TO AVOID ANY ADDITIONAL TRAUMA OR INJURY TO THE BLADDER. THE SURGICAL PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE WELL. POST-OPERATIVELY THE SURGEON DISCUSSED WITH THE PATIENT AND HER FAMILY THAT HE MADE THE DECISION TO PERFORM A SUPRACERVICAL HYSTERECTOMY INSTEAD OF A TOTAL HYSTERECTOMY. AFTER THE PATIENT WAS CLEARED BY CARDIOLOGY FOLLOWING AN EPISODE OF SUPRAVENTRICULAR TACHYCARDIA, SHE WAS DISCHARGED FROM THE HOSPITAL ON ABOUT (B)(6) 2011. ON (B)(6) 2011 THE PATIENT WAS ADMITTED INTO THE HOSPITAL'S EMERGENCY ROOM WITH A COMPLAINT OF ABDOMINAL PAIN AND DURING HER HOSPITALIZATION SHE EXPERIENCED AN EPISODE OF TACHYCARDIA. AN ABDOMINAL CT SCAN SHOWED THAT THE PATIENT HAD LEFT-SIDED HYDRONEPHROSIS AND HYDROURETER WITH A MARKED DELAYED CONTRAST OF THE LEFT KIDNEY. THE CT SCAN ALSO SHOWED THICKENING OF THE POSTERIOR BLADDER WALL AND FREE FLUID IN THE PELVIS SUBCUTANEOUS ALONG THE RIGHT VENTRAL ABDOMINAL WALL. THE PATIENT'S URINE WAS POSITIVE FOR PROTEIN, KETONES, HEMATURIA TO 50 AND RED BLOOD CELLS. THE PATIENT UNDERWENT A CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM AND STENT INSERTION. A SURGEON WHO HAD BEEN CONSULTED DURING THE SURGICAL PROCEDURE INDICATED THAT THE REPAIR TO THE PATIENT'S BLADDER WAS PERFORMED CORRECTLY WITHOUT ANY LEAKAGE AND THERE WAS NO TRANSECTION OR INJURY TO THE PATIENT'S URETER. IT WAS STATED THIS MOST LIKELY IS SECONDARY TO THE EDEMA AFTER HAVING INITIAL URETERAL STENT PLACEMENT FOR THE DA VINCI SURGERY. THE PATIENT WAS SCHEDULED FOR RELEASE FROM THE HOSPITAL THE NEXT DAY. NO ADDITIONAL RECORDS WERE MADE AVAILABLE." }, { "mdr_text_key": "11068930", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, 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. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SI HYSTERECTOMY 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": "" } ] }