{ "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": "2955842-2013-03317", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20130830", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130118", "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": "20130830", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "430920", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130830", "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": "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20130830", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTRUMENTS, ACCSS & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "37 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Adhesion(s)", "Fever", "Pain", "Vascular Dissection", "No Code Available" ] } ], "distributor_city": "", "date_report": "20130805", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3319414", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130805", "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": "3646023", "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 MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE DUE TO ABNORMAL UTERINE BLEEDING. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. ACCORDING TO THE INFORMATION IN THE OP REPORT, DURING THE SURGICAL PROCEDURE, A SMALL ARTERIAL BLEEDER FROM WHAT APPEARED TO BE FROM AN ASCENDING CERVICAL BRANCH WAS APPRECIATED. THERE WERE CONCERNS ABOUT FURTHER CONTINUATION OF CAUTERY ENERGY IN THIS AREA AND A CLIP WAS APPLIED TO CONTROL THE BLEEDING. BASED ON THE INFORMATION AS PROVIDED IN THE OP REPORT THERE WERE NO OTHER ISSUES ENCOUNTERED DURING THE SURGICAL PROCEDURE. AFTER COMPLETION OF THE SURGICAL PROCEDURE THE PATIENT'S URINE WAS FOUND TO BE CLEAR. A CYSTOSCOPE WAS PLACED AND IT WAS CONFIRMED THAT THERE WAS NO TRAUMA TO THE PATIENT'S URINARY COLLECTING SYSTEM, AS THE BLADDER MUCOSA WAS CLEAR. INDIGO CARMINE FROM BOTH URETERS WAS OBSERVED. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF FEVER AND PELVIC PAIN. A CT SCAN PERFORMED SHOWED 5 BY 3 CM COLLECTION ABOVE THE CLOSED VAGINAL CUFF. THE CT SCAN ALSO SHOWED STRICTURE OF THE RIGHT DISTAL URETER WITH SIGNIFICANT DILATION OF THE RIGHT URINARY COLLECTING SYSTEM. A PELVIC EXAMINATION FOUND THAT THE VAGINAL CUFF WAS INTACT WITHOUT DISRUPTION OR INFECTION ON THE VAGINAL MUCOSA. ON (B)(6) 2013, THE PATIENT UNDERWENT A CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAPHY AND A RIGHT STENT PLACEMENT. BASED ON THE INFORMATION INDICATED IN THE OP REPORT, EXAMINATION OF THE PATIENT'S BLADDER FOUND NO EVIDENCE OF STONES, TUMORS, OR OTHER LESIONS. GOOD EFFLUX OF URINE FROM THE LEFT URETERAL ORIFICE WAS OBSERVED; HOWEVER, THERE WAS NO EFFLUX OF URINE FROM THE RIGHT URETERAL ORIFICE. RETROGRADE PYELOGRAM PERFORMED SHOWED THAT THE DISTAL URETER WAS NARROW AND APPEARED TO BE COMPRESSED FROM EXTRINSIC COMPRESSION, BUT WAS PATENT AND CONTRAST DID FLOW TO THE DILATED MORE PROXIMAL PORTION. A STENT WAS INSTALLED WITH GOOD PLACEMENT CONFIRMED BY FLUOROSCOPY. CLEAR URINE WAS OBSERVED TO BE EFFLUXING AFTER A RETROGRADE PYELOGRAPHY WAS PERFORMED. THE CONTRAST DRAINED BRISKLY. AFTER COMPLETION OF THE PROCEDURE, THE PATIENT WAS AWAKENED, EXTUBATED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. ON (B)(6) 2013, THE PATIENT UNDERWENT A COLPOTOMY WITH IRRIGATION OF ABSCESS PROCEDURE. DURING THE PROCEDURE THERE WAS NO INDICATION THAT THE PATIENT SUFFERED ANY COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT UNDERWENT A LAPAROSCOPY, LYSIS OF ADHESION AND LEFT SALPINGO-OOPHORECTOMY PROCEDURE. EXAMINATION OF THE PATIENT'S VAGINAL CUFF FOUND NO ACTUAL MASS AND THE CUFF WAS FOUND TO BE INTACT WITH SOME LOOSENING OF SUTURE. REPORTEDLY, THE CUFF WAS SLIGHTLY OPEN DUE TO A PREVIOUS DRAINAGE PROCEDURE OF AN ABSCESS BASE. UNDER LAPAROSCOPY, THE PATIENT'S ANATOMY APPEARED NORMAL, WITH SOME ADHESIONS OF THE OMENTUM TO THE PELVIS. MINOR ADHESIONS TO BOTH THE LEFT PELVIC SIDEWALL AND THE RIGHT PELVIC SIDEWALL WERE NOTED AND THE LEFT OVARY WAS ENLARGED AND HAD MULTIPLE CYSTS. NO PURULENT MATERIAL WAS OBSERVED DURING DISSECTION. A LOT OF DISSECTION WAS REQUIRED TO LOCATE THE PATIENT'S LEFT OVARY AND DISSECT IT FREE AND CARE WAS TAKEN TO AVOID A BOWEL INJURY. THE PATIENT HAD A LARGE ADNEXA AND IT WAS ALSO REMOVED. THE SURGICAL AREA WAS IRRIGATED WITH COPIOUS AMOUNTS OF BACITRACIN. INTERCEED WAS PLACED OVER THE DISSECTED CUFF AREA AND THE AREA WHERE THE OVARY HAD BEEN FREED FROM THE SIDEWALL. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013." }, { "mdr_text_key": "11233561", "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 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. ISI HAS CONTACTED RISK MANAGEMENT GROUP AT THE SITE TO GATHER ADDITIONAL INFORMATION; 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 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED 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 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": "12/03/2013" } ] }