{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2022-12701", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220630", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220701", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2280651", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220630", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "380601-40", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250821", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220630", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Hematoma", "Unspecified Gastrointestinal Problem", "Failure to Anastomose", "Hematoma", "Unspecified Gastrointestinal Problem" ] } ], "distributor_city": "", "date_report": "20220602", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14881699", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220602", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "295125742", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE REPORTED COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED ILEOCOLIC RESECTIONS CANNOT BE DETERMINED OR IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE SURGERY ARTICLE TITLED, ¿PERIOPERATIVE OUTCOMES OF MINIMALLY INVASIVE ILEOCOLIC RESECTION FOR COMPLICATED CROHN DISEASE: RESULTS FROM A REFERRAL CENTER RETROSPECTIVE COHORT,\" OPERATIVE COMPLICATIONS WERE NOTED, INVOLVING PATIENTS WHO UNDERWENT DA VINCI-ASSISTED ILEOCOLIC RESECTION PROCEDURES. INTRAOPERATIVE COMPLICATIONS IN 4 PATIENTS WERE NOTED: 2 PATIENTS WITH UNINTENDED FULL-THICKNESS BOWEL INJURY; 1 PATIENT HAD A FULL-THICKNESS BOWEL INJURY; AND 1 PATIENT SUFFERED A DEVASCULARIZED MESENTERY, WHICH NECESSITATED ULTIMATE SMALL BOWEL RESECTION. SURGICAL COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE, INTRA-ABDOMINAL ABSCESS, PERITONITIS, WOUND COMPLICATIONS, ILEUS, SMALL BOWEL OBSTRUCTION, INTRAABDOMINAL HEMATOMA, ANEMIA REQUIRING TRANSFUSION, STOMA RELATED COMPLICATIONS, AND ANASTOMOTIC BLEEDING, AND CONVERSION TO OPEN SURGERY. AT THE TIME OF THIS REPORT, THE ROOT CAUSES OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE COMPLICATIONS. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURER." }, { "mdr_text_key": "295125743", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A SURGERY ARTICLE TITLED, ¿PERIOPERATIVE OUTCOMES OF MINIMALLY INVASIVE ILEOCOLIC RESECTION FOR COMPLICATED CROHN DISEASE: RESULTS FROM A REFERRAL CENTER RETROSPECTIVE COHORT¿ (ABDALLA, S., ET AL., 2022). A STUDY WAS CONDUCTED TO COMPARE THE INTRAOPERATIVE AND POSTOPERATIVE OUTCOMES OF MINIMALLY INVASIVE ILEOCOLIC RESECTION (MISICR) FOR COMPLICATED VERSUS UNCOMPLICATED CROHN DISEASE (CD). A RETROSPECTIVE ANALYSIS OF ALL CONSECUTIVE ADULT PATIENTS WITH CD UNDERGOING MISICR FROM 01-SEP-2014 AND 31-MAR-2021 WAS CONDUCTED. PATIENTS WERE DIVIDED INTO 2 GROUPS, COMPLICATED AND UNCOMPLICATED, BASED ON THE PREOPERATIVE AND INTRAOPERATIVE FINDINGS. PERIOPERATIVE OUTCOMES WERE COMPARED BETWEEN PATIENTS WITH COMPLICATED CD (COMPLICATED GROUP) AND PATIENTS WITHOUT THESE LESIONS (UNCOMPLICATED GROUP). THE FOCUSED WAS ON ROBOTIC AND LAPAROSCOPIC ILEOCOLIC RESECTIONS (ICR) FOR CD. WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: INTRAOPERATIVE COMPLICATIONS OCCURRED IN 4 PATIENTS WITHOUT DIFFERENCES BETWEEN GROUPS. IN THE UNCOMPLICATED GROUP, 2 PATIENTS HAD AN UNINTENDED FULL-THICKNESS BOWEL INJURY WHICH WAS REPAIRED. IN THE COMPLICATED GROUP, 1 PATIENT HAD A FULL-THICKNESS BOWEL INJURY. ONE PATIENT SUFFERED A DEVASCULARIZED MESENTERY WHICH NECESSITATED A SMALL BOWEL RESECTION. SURGICAL COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE, INTRA-ABDOMINAL ABSCESS, PERITONITIS, WOUND COMPLICATIONS, ILEUS, SMALL BOWEL OBSTRUCTION, INTRAABDOMINAL HEMATOMA, ANEMIA REQUIRING TRANSFUSION, STOMA RELATED COMPLICATIONS, AND ANASTOMOTIC BLEEDING, AND CONVERSION TO OPEN SURGERY. THERE WAS NO DIFFERENCE IN THE CONVERSION RATE BETWEEN BOTH GROUPS. INTRA-ABDOMINAL SEPTIC COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE, POSTOPERATIVE PERITONITIS, AND INTRA-ABDOMINAL ABSCESS. MEDICAL COMPLICATIONS INCLUDED CARDIAC, PULMONARY INFECTION, DVT/PE, URINARY TRACT INFECTION, ACUTE URINARY RETENTION, ACUTE KIDNEY INJURY, OR THROMBOTIC EVENTS AND/OR INFECTIONS (OTHER THAN WOUND INFECTIONS). THIRTY-DAY POSTOPERATIVE OUTCOMES: MORTALITY WAS NIL, AND OVERALL MORBIDITY WAS 29.6%, MOST OF WHICH WERE CLAVIEN-DINDO 2 COMPLICATIONS (80.2%), AND WITHOUT ANY DIFFERENCE BETWEEN BOTH GROUPS. IT IS CONCLUDED IN THE ARTICLE THAT THE MINIMALLY INVASIVE APPROACH FOR ICR IN PATIENTS WITH COMPLICATED PENETRATING CD IS SAFE AND FEASIBLE. FURTHERMORE, IT IS CONCLUDED THAT MISICR PROVIDES SIMILAR INTRAOPERATIVE AND POSTOPERATIVE OUTCOMES AS IN PATIENTS WITHOUT ANY COMPLICATING FACTORS. ISI CONTACTED THE ARTICLE CORRESPONDENCE TO GATHER ADDITIONAL INFORMATION REGARDING THE ARTICLE INFORMATION. PER THE ARTICLE CORRESPONDENCE, THE SITE DOES NOT SHARE DATA WITH OUTSIDE COMPANIES. HOWEVER, HE INDICATED THAT THERE ARE NO INSTRUMENT ISSUES ASSOCIATED WITH ANY OF THE PATIENTS. THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A SPECIFIC DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO ISI FOR FAILURE ANALYSIS EVALUATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }