{ "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": "2955842-2015-00939", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150625", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150521", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150626", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "411198", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150625", "brand_name": "DA VINCI SI 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": "IS3000 A6.0P9", "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": [ "Human-Device Interface Problem" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20150625", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Physical Entrapment" ] } ], "distributor_city": "", "date_report": "20150528", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4869942", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150528", "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": "6045993", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. IT WAS LATER FOUND THAT A PORTION OF THE PATIENT'S BOWEL WAS STUCK TO THE FASCIA. ONE OF THREE POSSIBLE EXPLANATIONS OFFERED BY THE SITE FOR THE ISSUE WAS THAT A PART OF THE PATIENT'S BOWEL COULD HAVE GOTTEN CAUGHT ON THE END OF A CANNULA DURING REMOVAL. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HE STATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE ROBOTICS COORDINATOR INDICATED ON POST-OPERATIVE DAY 1, THE PATIENT HAD COMPLAINTS OF ABDOMINAL PAIN WHILE SHE WAS IN THE ICU. THE PATIENT WAS TAKEN BACK TO THE OR. A 2-3MM PORTION OF THE PATIENT'S BOWEL WAS FOUND TO BE STUCK TO THE FASCIA WHERE ONE OF THE CANNULA PORTS WAS LOCATED. AT THE CONCLUSION OF THE DA VINCI HYSTERECTOMY PROCEDURE, THE SURGEON DID NOT CLOSE THE 8MM PORT SITE FASCIA WITH SUTURES. ACCORDING TO THE ROBOTICS COORDINATOR, THE SURGEON ONLY CLOSES THE SKIN OF 8MM PORT SITES. THE ROBOTICS COORDINATOR COULD NOT RECALL WHAT SPECIFIC PORT WAS INVOLVED. THE SURGEON REOPENED THE PORT AND MANUALLY PUSHED THE BOWEL OUT OF THE PORT SITE FASCIA. THE ROBOTICS COORDINATOR CONCLUDED THAT THERE WERE 3 POSSIBLE CAUSES FOR THE OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT: POSSIBLY BOWEL TISSUE GOT CAUGHT ON THE END OF ONE OF THE 8MM CANNULAS DURING REMOVAL AND THE BOWEL ULTIMATELY GOT STUCK IN THE PORT SITE FASCIA; POSSIBLY BOWEL GOT SUCKED UP THE PORT DURING RAPID RELEASE OF CARBON DIOXIDE AT THE CONCLUSION OF THE SURGICAL PROCEDURE; OR BOWEL TISSUE GOT STUCK THROUGH THE PORT AS A RESULT OF BEING IN STEEP-TRENDELENBURG POSITION. THE ROBOTICS COORDINATOR STATED THAT ALL THE 8MM CANNULAS WERE INSPECTED AND NO ISSUES WERE FOUND. HE ALSO INDICATED THAT THE 8MM CANNULAS HAVE BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES AND THERE HAVE BEEN NO RECURRENCES OF THE REPORTED ISSUE. THE ROBOTICS COORDINATOR ALSO INDICATED THAT HE WILL NOW HAVE THE SURGEONS REMOVE CANNULAS AT THE END OF DA VINCI SURGICAL PROCEDURES WITH DIRECT VISUALIZATION. THE PATIENT HAS SINCE BEEN DISCHARGED WITH NO POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "13478992", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S OPERATIVE COMPLICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED A POST-OPERATIVE COMPLICATION AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE AND REQUIRED ADDITIONAL MEDICAL INTERVENTION TO PUSH OUT BOWEL THAT APPARENTLY GOT STUCK IN PORT SITE FASCIA. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S OPERATIVE COMPLICATION IS UNKNOWN." } ], "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": "" } ] }