{ "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": "2955842-2013-03955", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131004", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110303", "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": "20131004", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "502234", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131004", "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", "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": "20250804", "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": "20131004", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "59", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn, Thermal", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20130905", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3386307", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140813", "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": "18099082", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. 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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL SACROCOLPOPEXY PROCEDURE." }, { "mdr_text_key": "12351415", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED ROBOTIC PROCEDURE - SACRAL COLPOPEXY, POSTERIOR COLPORRHAPHY, SLING PROCEDURE, AND CYSTOSCOPY FOR VAGINAL VAULT PROLAPSE, CYSTOCELE, RECTOCELE, AND STRESS INCONTINENCE ON (B)(6) 2011. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND OTHER MEDICAL RECORDS. PER THE OPERATIVE REPORT, THERE WAS A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM/INSTRUMENT DURING THE OPERATION, WHICH RESULTED IN A COMPLICATION. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, I WAS LIFTING THE BOWEL TO MOVE IT USING THE MARYLAND. HOWEVER, I DID NOT HAVE MY FOOT ON THE PEDAL. HOWEVER, THE BIPOLAR APPEARED TO AUTOMATICALLY DISCHARGE AND CAUTERIZE WITHOUT MY FOOT ON THE PEDAL. I IMMEDIATELY REMOVED IT FROM THE BOWEL AND DID NOTICE THAT THERE WAS A BOWEL BURN. WE TOOK THE INSTRUMENT AWAY FROM ANY TISSUE AND PUT THE 2 TIPS TOGETHER AND AGAIN IT DID THE SAME THING WHERE IT ACTIVATED SPONTANEOUSLY. AT THIS POINT, THAT INSTRUMENT WAS IMMEDIATELY REMOVED AS WAS THE ELECTRIC GENERATOR THAT IT WAS ATTACHED TO. WE THEN WAITED AND REATTACHED TO IT ANOTHER GENERATOR AND TESTED IT PRIOR TO USING IT AGAIN AND IT APPEARED TO BE FUNCTIONING NORMALLY AT THIS POINT. THE SURGEON ALSO NOTED, ¿ I CONSULTED GENERAL SURGERY TO LOOK AT THE AREA OF BURN ON THE BOWEL. THEY DETERMINED IT COULD BE OVERSEWN WITH A SERIES OF INTERRUPTED SUTURES. THE ROBOT WAS UNDOCKED FROM THE PATIENT AND ANOTHER SURGEON WAS ABLE TO REPAIR THE BOWEL DEFECT. AFTER THE REPAIR WAS PERFORMED, THE SURGICAL STAFF REDOCKED THE ROBOT TO THE PATIENT AND THE DA VINCI SURGICAL PROCEDURE WAS CONTINUED. AT THE END OF THE REPORT, THE SURGEON DICTATED, THE PATIENT WAS RETURNED TO THE SUPINE POSITION. SHE WAS AWOKEN. SHE WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE FAMILY WAS INFORMED OF THE THERMAL INJURY AND THE CAUSE OF IT AND THE REPAIR OF IT. THE GENERAL SURGEON'S DICTATED OPERATIVE REPORT STATES, THE INJURY DID NOT APPEAR TO BE FULL THICKNESS, BUT THE AREA APPEARED TO BE BLANCHED AND PALE. THE SURGEON ELECTED TO PROCEED WITH IMBRICATION OF THE INJURY. NO FURTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "17953646", "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 THAT UNDERWENT A DA VINCI S SACROCOLPOPEXY POSTERIOR COLPORRHAPHY AND SLING PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT SUSTAINED A PUNCTURED BOWEL DUE TO A THERMAL BURN. NO SPECIFIC ALLEGATION OF A MALFUNCTION WITH THE DA VINCI S SYSTEM, INSTRUMENTS, OR ACCESSORIES WAS REPORTED. NO OTHER 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": "09/12/2014" } ] }