{ "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": "2955842-2013-03308", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130830", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120213", "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": "429416", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130830", "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, A60.P8", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250813", "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 S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20131008", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3318237", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131008", "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": "18705820", "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 THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE; 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. BASED ON THE LEGAL COMPLAINT, THE REPORTED DA VINCI S SURGICAL PROCEDURE OCCURRED ON OR ABOUT (B)(6) 2012. THERE WERE NO SYSTEM LOGS FOUND FOR (B)(6) 2012. REVIEW OF THE SITE'S SYSTEM LOGS FOR (B)(6) 2012 REVEALED THERE WERE NO SYSTEM ERRORS THAT WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI ENDOMETRIOSIS RESECTION AND OVARY CYSTECTOMY SURGICAL PROCEDURE." }, { "mdr_text_key": "18469280", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL COMPLAINT, WHICH INDICATED THAT A PATIENT ALLEGEDLY EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER A DA VINCI S SURGICAL PROCEDURE IN (B)(6) 2012. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MEDICAL SERVICES AND CARE INCLUDING DIAGNOSTIC PROCEDURES AND MEDICAL TREATMENT (DETAILS WERE NOT PROVIDED) ON OR ABOUT (B)(6) 2012. ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI SI SURGICAL PROCEDURE FOR ENDOMETRIOSIS RESECTION, OVARIAN CYSTECTOMY, AND EXTENSIVE LYSIS OF ADHESIONS INCLUDING ENTEROLYSIS. THE LEGAL COMPLAINT ALLEGES THAT THE PATIENT POST-OPERATIVELY EXPERIENCED AN INFECTION RESULTING FROM A BOWEL PERFORATION, WHICH LED TO THE PATIENT UNDERGOING SURGERY FOR SIGMOID COLECTOMY ON AN UNSPECIFIED DATE. NO MEDICAL REPORTS, CHARTS, OR OPERATIVE REPORTS WERE PROVIDED." }, { "mdr_text_key": "24821353", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2012 FOR DIAGNOSTIC LAPAROSCOPY WITH EXTENSIVE ENTEROLYSIS, RESECTION OF ENDOMETRIOMAS, OVARIAN CYSTECTOMY, AND BILATERAL SALPINGO LYSIS AND OVARIAN CYSTECTOMIES. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) AND WAS FOUND TO HAVE BILATERAL ADNEXAL MASSES, ON CT SCAN WITH ASCITES, AND ADMITTED TO AT THE TIME TO UNDERGO DIAGNOSTIC WORKUP. THE PATIENT WAS TAKEN TO THE OPERATING ROOM. AT THE TIME OF HER EXAMINATION UNDER ANESTHESIA, THE PATIENT'S CERVIX WAS NOTED TO BE FRIABLE. THE ENDOCERVIX WAS OBLITERATED AND COULD NOT EASILY BE DILATED; THEREFORE A SPONGE STICK AND TENACULUM WAS USED FOR THE MANIPULATION OF THE UTERUS DURING THE PROCEDURE. IMMEDIATELY UPON ENTERING THE ABDOMINAL PELVIC CAVITY, CELL WASHINGS WERE TAKEN, AND A 15CM MASS WAS SEEN, INVOLVING ALL ADNEXA WITH MARKED INFLAMMATORY CHANGES TO THE PELVIS, MARKED ADHESION FORMATION, SCARRING OF THE FALLOPIAN TUBES, AND OBLITERATION OF THE POSTER CUL-DEL-SAC AND ANTERIOR CUL-DE-SAC. THE OMENTUM WAS DENSELY ADHERENT TO THE MASS. THEN THE DA VINCI SYSTEM PORTS WERE PLACED WITH NO INCIDENT. A MARYLAND BIPOLAR INSTRUMENT WAS USED TO RESECT THE OMENTUM OFF ITS ATTACHMENT TO THE PELVIC LESIONS. MULTIPLE ADHESIONS WERE TAKEN DOWN USING THE BOVIE CAUTERY AND THEN A LENGTHY, CONTINUOUS DISSECTION WAS CARRIED OUT TO MOBILIZE THE 15 CM MASS FROM THE PELVIC VISCERA AND FROM THE SMALL AND LARGE BOWEL. A LESION WAS RESECTED OFF OF THE COLON AND THE SMALL INTESTINE, WHICH REQUIRED A LENGTHY 2.5 TO 3 HOURS DISSECTION TO GET BACK TO NORMAL VISCERA. THE PATIENT TOLERATED THE PROCEDURE WITHOUT DIFFICULTY AND LEFT THE OPERATING ROOM IN SATISFACTORY CONDITION. NO OTHER MEDICAL RECORDS WERE PROVIDED. BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE PATIENT HAD LARGE 15CM MASS AND SIGNIFICANT BOWEL ADHESIONS, WHICH REQUIRED LENGTHY DISSECTIONS. DUE TO THE PATIENT'S SIGNIFICANT BOWEL ADHESIONS, HER RISK OF BOWEL INJURIES INCREASES REGARDLESS OF THE TYPE OF SURGICAL METHOD. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, I INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. 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 SURGICAL 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": "11/05/2013" } ] }