{ "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": "2955842-2013-04895", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20070412", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562269", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "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": "20131101", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "62", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Anemia", "Purulent Discharge", "Fever", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Internal Organ Perforation", "Pain", "Abnormal Vaginal Discharge", "Weakness" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3443602", "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": "3900186", "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 DA VINCI S RADICAL HYSTERECTOMY WITH BILATERAL, SALPINGO-OOPHORECTOMY (WERTHEIM OPERATION), AND BILATERAL PELVIC AND PARAAORTIC LYMPHADENECTOMY WITH ROBOTIC LAPAROSCOPIC APPROACH, PARTIAL VULVECTOMY (POSTERIOR PERINEUM), EXCISION OF POSTERIOR VULVAR LESION FROM THE RIGHT VULVA FOR CERVICAL CANCER, STAGE 1B-1, AND VULVAR CARCINOMA IN SITU AND VULVAR LESION ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS ((B)(6) 2007, (B)(6) 2008, (B)(6) 2009, (B)(6) 2010, (B)(6) 2013). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H &P): (B)(6) 2007; (B)(6) 2013; DISCHARGE SUMMARIES: (B)(6) 2007, (B)(6) 2008, (B)(6) 2013 UROLOGY CONSULTATION/EVALUATION/FOLLOW-UP (F/U): (B)(6) 2008, (B)(6) 2009, (B)(6) 2010, (B)(6) 2012, (B)(6) 2013. 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. INTRAOPERATIVELY, AN EEA SIZER WAS PLACED IN THE VAGINA, A PNEUMOPERITONEUM CREATED THROUGH A LEFT UPPER QUADRANT INCISION AND A PARA-AORTIC AND BILATERAL PELVIC LYMPHADENECTOMY WAS CARRIED OUT USING THE GYRUS DEVICE, ELECTROCAUTERY AND SHARP DISSECTION. THE URETERS WERE VISUALIZED BILATERALLY AND NOTED TO BE PERISTALSING NORMALLY AND OF NORMAL CALIBER. THE UTERUS WAS MOBILIZED CIRCUMFERENTIALLY AND AFTER A COLPOTOMY THE SPECIMEN, WHICH INCLUDED THE UTERUS, CERVIX, UPPER VAGINA, PARAMETRIA, PARAVAGINAL TISSUES, BILATERAL TUBES AND OVARIES, WAS REMOVED THROUGH THE VAGINA. THE VAGINAL CUFF WAS THEN REAPPROXIMATED WITH INTERRUPTED 0 VICRYL SUTURES, INTERRUPTED 0 VICRYL FIGURE OF EIGHT SUTURES AND A RUNNING 0 VICRYL SUTURE. SUBSEQUENTLY, INDIGO CARMINE WAS INJECTED INTRAVENOUSLY, AND THE URETERS WERE NOTED TO BE INTACT BILATERALLY. THE BLADDER WAS TESTED WITH 200 CC OF STERILE METHYLENE BLUE AND SALINE AND NOTED TO BE INTACT AND FREE OF ANY LEAKAGE. AT THE END OF THE OPERATION 2 SEPARATE LESIONS AT THE VULVAR WERE REMOVED WITH A PARTIAL VULVECTOMY AND THE DEFECT CLOSED. HER POSTOPERATIVE COURSE WAS RELATIVELY UNEVENTFUL WITH THE EXCEPTION OF SOME MILD NAUSEA AND A RIGHT EYE CORNEAL ABRASION SUSTAINED. THE PATIENT WAS DISCHARGED WITH FOLEY IN PLACE ON (B)(6) 2007. SHE WAS TOLERATING REGULAR DIET, AMBULATING, WITH PAIN WELL CONTROLLED. ON (B)(6) 2007 SHE NOTED ONSET OF WEAKNESS AND VAGINAL BLEEDING. SHE WAS SEEN IN THE EMERGENCY ROOM AND FOUND TO HAVE A BLOOD PRESSURE OF 61/45 AND SHE RECEIVED 2 UNITS OF RED BLOOD CELLS (RBC). THAT DAY SHE UNDERWENT AND EMERGENCY SURGERY WITH LAPAROSCOPIC EXAM FOLLOWED BY LAPAROTOMY WITH REPAIR OF AN ILIAC ARTERY INJURY. ON INSPECTION A LARGE CLOTTED AREA IN THE PELVIC AREA WAS FOUND. THE VAGINAL CUFF WAS EXAMINED AND WAS COMPLETELY INTACT. THE RIGHT ILIAC AREA APPEARED INTACT, AS WERE BOTH URETERS. THE LEFT URETER WAS VISUALIZED, AND CASED IN SOME ADHERENT TISSUE. A FINAL CLOT WAS FOUND IN THE LEFT ILIAC AREA. ACTIVE BLEEDING WAS NOTED WHEN THIS WAS REMOVED AND AN OPENING IN A SMALL BRANCH IMMEDIATELY ADJACENT TO THE MAIN ILIAC ARTERY WAS VISUALIZED AND CONTROLLED WITH A SET OF 4 CLIPS. PATIENT DID WELL FROM THE SURGERY WITH POSTOPERATIVE HEMATOCRIT 35.6% AFTER PROVIDING BLOOD TRANSFUSIONS. ON THE (B)(6) 2007, THE PATIENT WAS HAVING A LOW-GRADE FEVER AND SOME INCREASING ABDOMINAL DISCOMFORT. A CT OF THE PELVIS BECAUSE WAS PERFORMED WITHOUT PROOF OF A DEFINITE FISTULA. THE PATIENT WAS PLACED ON ANTIBIOTICS AND BEGAN HAVING INCREASING FOUL-SMELLING DISCHARGE THROUGH THE VAGINAL CUFF. THE WOUND ALSO BECAME INFECTED AND REQUIRED INCISION AND DRAINAGE AND EVACUATION. ON (B)(6) 2007, DRAINAGE OF AN INCISIONAL WOUND ABSCESS AND A PELVIC INFECTION WAS PERFORMED. THERE WERE SEVERAL HUNDRED ML OF DRAINAGE WITHIN THE INCISION, BUT THE FASCIA APPEARED TO BE INTACT. WITH THIS, THE WOUND WAS LEFT OPEN AND PACKED. VAGINAL EXPLORATION EXPRESSED ABOUT 300 TO 400 ML OF PURULENT DRAINAGE FROM THE VAGINAL CUFF AS WELL. THE PATIENT IMPROVED SUBSEQUENTLY UNDER CONSERVATIVE THERAPY WITH WOUND CARE, ANTIBIOTICS, SUPPORTIVE THERAPY AND ON TPN. THE WOUND VACUUM ASSISTED CLOSURE (VAC) WAS PLACED, BUT BECAUSE OF CONTINUED VAGINAL DRAINAGE, A GASTROGRAFIN BARIUM ENEMA WAS PERFORMED WHICH CONFIRMED THE SUSPICION FOR A RECTAL FISTULA COMING FROM THE RECTO- SIGMOID ANGULATION. REFER TO FOLLOW-UP 1 MDR FOR ADDITIONAL MEDICAL RECORD INFORMATION." }, { "mdr_text_key": "11239989", "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 FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL PROCEDURE." }, { "mdr_text_key": "17775755", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2007, THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY. ON (B)(6) 2008, SHE PRESENTED WITH FECAL URIA AND IS ALSO HAVING URINE IN HER VAGINA AND IN HER RECTUM SUGGESTING A COLOVESICOVAGINAL FISTULA WITH POSSIBLE INVOLVEMENT OF THE URETER. ON (B)(6) 2008, A CYSTOSCOPY WITH BILATERAL RETROGRADE PYELOURETEROGRAMS, INTRAOPERATIVE CYSTOGRAM AND A RIGHT URETEROSTOMY WITH PLACEMENT OF BILATERAL URETERAL STENTS WAS PERFORMED FOR A COLOVAGINAL FISTULA WITH PROBABLE COLO-VAGINAL URETERAL FISTULA INVOLVING THE RIGHT DISTAL URETER. ON (B)(6) 2008, THE PATIENT WAS READMITTED WITH COMPLAINTS OF VAGINAL DISCHARGE CONSISTENT WITH A FISTULA AND WANTED THIS REPAIRED. AN EXPLORATION REVEALED A DEFINITE COLOVAGINAL FISTULA CONNECTED TO THE LEFT VAGINAL CUFF. THE COLON WAS COMPLETELY DETACHED FROM THE VAGINA AND THE OPENING WAS REPAIRED. TISSUE WAS IN THE SPACE BETWEEN THE COLON AND VAGINA. THE VAGINAL CUFF WAS ACTUALLY RE-ENTERED DURING THAT PROCEDURE AND EXAMINED, AND THERE WAS NO OTHER CONNECTION AND THE BLADDER LIKEWISE LOOKED CLEAR. THE VAGINAL CUFF WAS CLOSED COMPLETELY WITH ABSORBABLE SUTURE. A LARGE VENTRAL HERNIA WAS ALSO REPAIRED BY A PRIMARY CLOSURE. POSTOPERATIVELY, THE PATIENT DID EXTREMELY WELL AND WAS DISCHARGED HOME ON (B)(6) 2008. (B)(6) 2008 - CYSTOSCOPY WITH BILATERAL RETROGRADE PYELOURETEROGRAMS WAS PERFORMED IN ADDITION TO PLACEMENT OF A URETERAL STENT. (B)(6) 2009 - CYSTOSCOPY WITH RIGHT RETROGRADE PYELOURETEROGRAM WITH EXCHANGE OF RIGHT URETERAL STENT WAS PERFORMED. (B)(6) 2009 - CYSTOSCOPY WITH RIGHT RETROGRADE PYELOURETEROGRAM WITH RIGHT URETEROSCOPY WITH IDENTIFICATION OF THE FISTULOUS TRACT WITH EXCHANGE OF POLARIS URETERAL STENT WAS PERFORMED. (B)(6) 2010 - CYSTOSCOPY WITH PLACEMENT OF A 26 EM X 5.0 FRENCH POLARIS URETERAL STENT WAS PERFORMED. (B)(6) 2010 - THE PATIENT WAS READMITTED AND UNDERWENT STENT REPLACEMENT AND A CYSTOSCOPY. A VENTRAL HERNIA REPAIR WAS PERFORMED AND THE ENTIRE LOWER INCISION WAS FOUND TO BE QUITE WEAKENED. A PIECE OF MESH 14 X 11 CM IN SIZE HAD TO BE PLACED IN THE PREFASCIAL REGION. THE REPAIR WAS UNEVENTFUL AND TOLERATED NICELY. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. (B)(6) 2010 - CYSTOSCOPY, RIGHT URETERAL STENT REMOVAL, AND RIGHT RETROGRADE PYELOGRAM WAS PERFORMED. (B)(6) 2013 - PATIENT STILL HAD LARGE AMOUNTS OF INCONTINENCE. SHE CAME IN DESIRING SOMETHING DEFINITIVE TO BE DONE TO REPAIR THE FISTULA. SHE CAME IN PRELIMINARILY FOR A CYSTO, RETROGRADE URETEROSCOPY. (B)(6) 2013 - CYSTOSCOPY AND BILATERAL RETROGRADE PYELOGRAM WERE PERFORMED. (B)(6) 2013 - CYSTOSCOPY, PLACEMENT OF RIGHT URETERAL STENT, EXCISION OF URETEROVAGINAL FISTULA, AND PSOAS HITCH URETERONEOCYSTOSTOMY FOR URETEROVAGINAL FISTULA ON THE RIGHT SIDE WERE PERFORMED. (B)(6) 2013 - THE PATIENT WAS DISCHARGED. SHE TOLERATED THE PROCEDURE WELL, BUT WAS LEFT IN THE HOSPITAL FOR PAIN CONTROL AND ANTIBIOTIC THERAPY AND WAS DISCHARGED SEVERAL DAYS POSTOPERATIVELY AFTER THE ILEUS AND NAUSEA WERE GONE. (B)(6) 2013 - THE PATIENT HAD AN OUTPATIENT FOLLOW UP FOR STAPLE, FOLEY AND DRAIN REMOVAL. (B)(6) 2013 - THE PATIENT HAD AN OUTPATIENT FOLLOW UP FOR STENT REMOVAL. (B)(6) 2013 - THE PATIENT HAD AN OUTPATIENT FOLLOW UP. (B)(6)" } ], "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": "11/01/2013" } ] }