{ "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": "2955842-2013-04892", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130325", "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": "20131101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562577", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20131101", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "98", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Adhesion(s)", "Fistula", "Hemorrhage/Blood Loss/Bleeding", "Seroma" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3443533", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "3902399", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR UTERINE FIBROIDS AND PELVIC PAIN ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. A 12 WEEK SIZE, MOBILE UTERUS WAS OBSERVED. A VCARE UTERINE MANIPULATOR WAS PLACED. A VERESS NEEDLE WAS PLACED AND 3L OF CARBON DIOXIDE INSUFFLATED. PORT PLACEMENT WAS PERFORMED USING A 5MM LAPAROSCOPE THROUGH A VISIPORT TROCAR. A 12MM PORT WAS PLACED IN THE UMBILICUS. TWO 8MM PORTS WERE PLACED TO THE LEFT AND RIGHT OF THE UMBILICUS, LATERAL TO THE RECTUS MUSCLES. MARCAINE WAS INFILTRATED INTO THE SKIN AND AT THE PORT SITES. PATIENT WAS PLACED IN DEEP TRENDELENBURG AND THE ROBOT WAS BROUGHT TO THE RIGHT SIDE OF THE TABLE AND DOCKED. A FENESTRATED BIPOLAR WAS PLACED IN THE LEFT PORT AND A MONOPOLAR SCISSORS IN THE RIGHT PORT. THE UTERUS, TUBES, AND OVARIES WERE ATTEMPTED TO BE REMOVED THROUGH THE VAGINA BUT WERE TOO LARGE. THE ROBOT WAS UNDOCKED. A STEINER RETRACTOR WAS PLACED IN THE CUL-DE -SAC AND A RIGHT-ANGLE RETRACTOR UNDER THE BLADDER. A LAHEY THYROID CLAMP WAS PLACED ON THE CERVIX AND THE CERVIX WAS AMPUTATED. A RING FORCEPS WAS PLACED ON THE UTERUS FUNDUS. A WEDGE OF THE FIBROID MATERIAL WAS WEDGED OUT AND REMOVED. THE UTERUS WAS REMOVED FROM THE VAGINA. THE ROBOT WAS RE-DOCKED AND THE FOLLOWING PROCEDURE STEPS CONTINUED: THE VAGINAL CUFF WAS CLOSED WITH A RUNNING SUTURE USING A NEEDLE HOLDER IN THE RIGHT PORT AND COBRA FORCEPS IN THE LEFT PORT USING V-LOCK SUTURE. THE PELVIS WAS IRRIGATED AND SUCTIONED AND HEMOSTASIS WAS NOTED. THERE WERE NO COMPLICATIONS AND ESTIMATED BLOOD LOSS WAS 100CC. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PROCEDURE. NO DISCHARGE INFORMATION WAS AVAILABLE. ON (B)(6) 2013 THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, PELVIC LAVAGE, AND DRAINING OF THE PELVIS FOR PELVIC CELLULITIS WITH NO EVIDENCE OF ABSCESS AND NO EVIDENCE OF BOWEL INJURY. INTRAVENOUS ANTIBIOTICS WERE GIVEN. IT WAS NOTED THAT 10-15CC OF GEROSANQUINEOUS FLUID WAS FOUND WITH IN THE PELVIS. IT WAS ALSO NOTED THAT THE PATIENT'S APPENDIX HAD BEEN ADHERED IN THE PELVIS. NO ABNORMALITIES AND NO EVIDENCE OF ENTERIC INJURY WERE FOUND. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2013 THE PATIENT UNDERWENT A CYSTOSCOPY WITH BILATERAL RETROGRADE PYELOGRAMS, RIGHT URETERAL STENT PLACEMENT, AND INTRAOPERATIVE FLUOROSCOPY. NO ABNORMALITY WAS FOUND WITH IN THE BLADDER OR URETHRA. NARROWING OF THE LEFT MID-URETER WAS NOTED HOWEVER THIS DID NOT RESULT IN ANY SIGNIFICANT HYDRONEPHROSIS OR DILATION OF THE PROXIMAL SYSTEM AND DRAINED BRISKLY. IT WAS NOTED THAT THE RIGHT URETER HAS GROSS EXTRAVASATION OF CONTRAST FROM THE DISTAL URETER, APPROXIMATELY 5MM UP FROM THE URETERAL ORIFICE AND PROXIMAL HYDROURETERONEPHROSIS. A STENT WAS SUCCESSFUL PLACED. THERE WERE NO COMPLICATIONS NOTED. ON (B)(6) 2013 THE PATIENT UNDERWENT AN APPENDECTOMY BY ONE SURGEON AND AN ABDOMINAL REPAIR OF URETEROVAGINAL FISTULA WITH URETEROLYSIS, PELVIC ADHESIOLYSIS, AND RIGHT URETERAL NEOCYSTOSTOMY WITH PSOAS HITCH BY A SECOND SURGEON. THE DIAGNOSIS WAS RIGHT URETEROVAGINAL FISTULA, RIGHT URETERAL STENOSIS, AND PREVIOUS HISTORY OF POSSIBLE APPENDICITIS. NO COMPLICATIONS WERE NOTED BY EITHER SURGEON. EXTENSIVE ADHESIONS WERE NOTED IN THE PELVIS AND WERE NOTED AS RELATED TO HER PREVIOUS HYSTERECTOMY. EXTENSIVE FIBROSIS OF THE PELVIC SIDE WALL WAS NOTED UP TO THE LEVEL JUST ABOVE THE ILIAC VESSELS. IT WAS NOTED THAT THE RIGHT URETERAL WAS FREED FROM THE ILIAC VESSELS AND RE-ATTACHED TO THE POSTERIOR WALL. THE RIGHT URETERAL ORIFICE WAS EXCISED AND REPAIRED AS WELL. A NEW STENT WAS PLACED. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2013 THE PATIENT UNDERWENT A PROCEDURE TO DRAIN THE SURGICAL WOUND WITH WASHOUT AND PACKING. THE DIAGNOSIS WAS POST-OP WOUND DEHISCENCE AND WOUND SEROMA. THE WOUND BASE WAS FOUND TO HAVE A MODEST AMOUNT OF SEROSANQUINEOUS FLUID WITH NO POCKETS OF PURULENCE. THE WOUND WAS IRRIGATED, AND CAUTERY WAS USED TO ACHIEVE HEMOSTASIS AND THE WOUND WAS PACKED. NO COMPLICATIONS WERE NOTED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "11212655", "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. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED POST-SURGICAL COMPLICATIONS." }, { "mdr_text_key": "33502438", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "." } ], "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": "04/09/2015" } ] }