{ "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": "2955842-2015-00251", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150206", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150105", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150206", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "88667", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150206", "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", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20150206", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20150107", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4491758", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150107", "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": "5498586", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY PROCEDURE PERFORMED ON (B)(6) 2015, THE SURGEON EXPERIENCED AWKWARD MOVEMENT ON ARM-3. DURING THE SAME SURGICAL PROCEDURE, THE PATIENT'S SMALL BOWEL WAS REPORTEDLY PERFORATED. A SMALL BOWEL RESECTION WAS PERFORMED AND THE DA VINCI SURGICAL PROCEDURE WAS ABORTED. ON (B)(4) 2015, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED CUSTOMER FAILURE MODE OF ARM-3 MOVING AWKWARDLY. THE FSE TESTED AND INSPECTED THE SYSTEM, AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. NO PART REPLACEMENTS WERE REQUIRED. ON (B)(4) 2015, ISI RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON. PRIOR TO PERFORMING THE REPORTED DA VINCI SURGICAL PROCEDURE, THE SURGEON HAD PERFORMED 2 OTHER DA VINCI SURGICAL PROCEDURES EARLIER THAT SAME DAY WITHOUT ANY ARM ISSUES. THE SURGEON INDICATED, THE AWKWARD MOVEMENT WAS PRIMARILY THE CAMERA ARM WHEN REACHING A NEAR MAXIMUM WORKING UP ON THE LEFT SIDE WALL ON ADHESIONS. THE THIRD ARM APPEARED TO BE FORCEFULLY JOSTLED UPON THE 'SPASM' OR JERKING MOVEMENT OF THE CAMERA. ON ARM 3, A PROGRASP FORCEPS INSTRUMENT WAS INSTALLED BUT AT THE TIME OF THE INJURY, ARM 3 WAS NOT THE ACTIVE ARM. THE SURGEON WAS UNCERTAIN WHAT DEFINITIVELY CAUSED THE BOWEL INJURY WHICH HE DESCRIBED AS A SMALL BOWEL 'BUCKET HANDLE' THROUGH AND THROUGH INJURY ROUGHLY 1 CM LONG. HOWEVER, HE BELIEVES THAT ARM 3 WAS MOVED FORCEFULLY BY THE CAMERA'S JERKING MOTION WHILE HOLDING THE SMALL BOWEL OUT OF THE WAY AND THIS MIGHT HAVE CAUSED THE BOWEL INJURY. DURING THE SURGICAL PROCEDURE, THE SURGICAL STAFF DID NOT NOTICE ANY ISSUES WITH THE PROGRASP FORCEPS INSTRUMENT. TO THE SURGEON'S KNOWLEDGE, THERE WERE NO REPORTS OF ANY INSTRUMENT COLLISIONS. AFTER THE PATIENT INJURY OCCURRED, THE SURGEON DID NOT CONTINUE ANY SIGNIFICANT SURGERY OTHER THAN ASSURING THAT NO OTHER INJURIES HAD OCCURRED. THE BOWEL INJURY WAS REPAIRED VIA TRADITIONAL LAPAROSCOPIC TECHNIQUES USING A 2.5-3.0 CM MINILAP EXTENSION OF THE UMBILICAL INCISION TO BRING THE LOOP OF AFFECTED BOWEL EXTERNALLY. THE SURGEON ALSO INDICATED THAT NO OBVIOUS SPILLAGE OF BOWEL CONTENTS WAS EVER NOTED. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED ON POST-OP DAY 2. THERE WERE NO REPORTS OF FEVER OR POST-OPERATIVE COMPLICATIONS. THE PATIENT HAD GOOD PAIN CONTROL AND A RAPID NORMALIZED WBC COUNT. ACCORDING TO THE SURGEON, THERE HAVE BEEN NO RECURRENCES OF THE REPORTED ARM 3 ISSUE AT THE SITE." }, { "mdr_text_key": "12877187", "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 INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. TWO DAYS AFTER THE EVENT OCCURRED, A FSE PERFORMED A FIELD EVALUATION AT THE SITE AND WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED ISSUE OF AWKWARD MOVEMENT ON ARM-3. 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 INTRA-OPERATIVE INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BOWEL PERFORATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE INJURY IS UNKNOWN. NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM WAS FOUND DURING A FIELD EVALUATION BY THE FSE." } ], "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": "" } ] }