{ "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": "2955842-2013-04979", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20090326", "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": "562489", "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": "", "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": "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": "20131101", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Edema", "Erythema", "Hemorrhage/Blood Loss/Bleeding", "Internal Organ Perforation", "Pain", "Swelling", "Thrombosis", "Perforation of Vessels" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444379", "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": "17503168", "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 OPERATIVE COMPLICATIONS 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 OPERATIVE COMPLICATIONS FROM UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "17128321", "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 SACRAL COLPOPEXY FOR TOTAL VAGINAL PROLAPSE ON (B)(6) 2009. THE PROCEDURE WAS CONVERTED TO AN OPEN SACRAL COLPOPEXY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: ADMISSION NOTES, POST-OP NOTES, DISCHARGE SUMMARY, UROLOGY CLINIC NOTES (B)(6) 2009 PRIOR TO THE PROCEDURE, THE RISKS AND BENEFITS OF SURGERY WERE DISCUSSED WITH THE PATIENT. THE PATIENT CHOSE TO UNDERGO A ROBOT-ASSISTED LAPAROSCOPIC SACRAL COLPOPEXY. THERE WAS INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION. PNEUMOPERITONEUM WAS ACHIEVED USING A DIRECT VISION TROCAR IN THE MIDLINE WITHOUT DIFFICULTY. THE CAMERA WAS THEN PLACED AND NO SIGNS OF A BOWEL INJURY WERE OBSERVED. FOUR OTHER PORTS WERE THEN PLACED AND THE TROCARS WERE PLACED UNDER DIRECT VISION AND LAPAROSCOPICALLY. THE ADHESIONS WERE TAKEN DOWN. THE ROBOT WAS THEN DOCKED. DURING TAKE DOWN OF DENSE ADHESIONS IN THE BOWEL AREA, A SMALL HOLE WAS MADE IN THE BLADDER. THE HOLE WAS SUTURE CLOSED USING A 2-0 VICRYL SUTURE THAT RESULTED IN A WATERTIGHT CLOSURE. AFTER THE VAGINA WAS IDENTIFIED WITH A RICHARDSON RETRACTOR AND THE SACRUM WAS IDENTIFIED, AN INCISION WAS MADE IN THE PERITONEUM AND TAKEN DOWN TO THE LEVEL OF THE SACRAL PROMONTORY. THE SURGEON NOTED THAT TWO SUTURES WERE PLACED IN THE SACRAL PROMONTORY. HOWEVER, THE SURGEON INDICATED THAT THE SECOND SUTURE MADE A SMALL HOLE IN A LARGE VEIN. PRESSURE WAS APPLIED VIA AN ASSISTANT PORT. UPON EXAMINATION OF THE BLEEDING, THE SURGEON MADE THE DECISION TO UNDOCK THE ROBOT AND CONVERT TO OPEN SURGICAL TECHNIQUES. DURING THE OPEN SURGERY, THE LEFT COMMON ILIAC VEIN NEAR THE BIFURCATION OF THE VENA CAVA WAS IDENTIFIED AS THE BLEEDING VESSEL. THE VENOTOMY WAS CLOSED AND REPAIRED WITH A SINGLE FIGURE-OF-8 SUTURE OF 5-HOLE PROLENE. ACCORDING TO THE SURGEON, INSPECTION OF THE VEIN REVEALED THAT FAR LESS THAN 50% OF THE LUMEN HAD BEEN COMPROMISED. THE SURGEON DETERMINED THAT NO OTHER REPAIR WAS NECESSARY. TOWARDS THE CONCLUSION OF THE SURGICAL PROCEDURE, THE SURGEON RE-INSPECTED THE VENOTOMY AND SHOWED NO BLEEDING AND THE URETERS WERE WITHIN NORMAL LIMITS. AT THE END OF THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2009, A CYSTOGRAM WAS PERFORMED. THE CYSTOGRAM SHOWED NO BLADDER INJURY OR LEAKAGE. THE PATIENT WAS DISCHARGED THAT SAME DAY AFTER HER FOLEY CATHETER WAS DISCONTINUED. DURING A FOLLOW-UP VISIT ON (B)(6) 2009, THE PATIENT WAS NOTED TO HAVE DEVELOPED A DEEP-VEIN THROMBOSIS (DVT). THE PATIENT WAS PLACED ON WARFARIN 5 MG WITH AN INR OF 2.4. SHE HAD COMPLAINTS OF LEFT LEG PAIN, EDEMA, AND ERYTHEMA. ON (B)(6) 2009, IT WAS NOTED IN A UROLOGY CLINIC NOTE THAT THE PATIENT WAS SEEN IN AN ER DUE TO COMPLAINTS OF LEFT LEG PAIN. IN THE ER, IMAGING SHOWED THE DVT WAS UNCHANGED. SHE WAS RESTARTED ON LOVENOX BECAUSE HER INR WAS ONLY 1.8. THE LEFT LEG WAS NOTED TO HAVE PITTING EDEMA AND MINIMAL ERYTHEMA. ON (B)(6) 2009, IT WAS NOTED IN A UROLOGY CLINIC NOTE THAT THE DVT AND SWELLING WERE GETTING BETTER. HER LEG WAS NON-TENDER BUT MILDLY SWOLLEN. DURING A FOLLOW-UP VISIT ON (B)(6) 2009, IT WAS NOTED THAT THE PATIENT WAS DOING VERY WELL AND HAD NO URINARY COMPLAINTS OR VAGINAL DISCHARGE OR IRRITATION. THE PATIENT WAS TO CONTINUE ON COUMADIN. ON (B)(6) 2009, ULTRASOUNDS OF THE PATIENT'S LEFT LOWER EXTREMITY REVEALED PROMINENT THROMBOSIS IN THE LEFT COMMON FEMORAL VEIN EXTENDING THROUGHOUT THE SUPERFICIAL FEMORAL, POPLITEAL, PERONEAL, AND POSTERIOR TIBIAL VEINS. DURING A FOLLOW-UP VISIT ON (B)(6) 2009, THE PATIENT'S LEFT LOWER EXTREMITY WAS NOTED TO HAVE PAIN ON PALPITATION. THERE WAS SOME MILD AMOUNT OF EDEMA. SHE WAS TO CONTINUE ON COUMADIN NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }