{ "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": "2955842-2014-00897", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20140214", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140115", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20140214", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "98604", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140214", "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 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20140122", "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": [ "Disconnection" ], "reporter_state_code": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20140214", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20140115", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3629550", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140115", "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": "16916658", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI OVARIAN CYSTECTOMY PROCEDURE, THE PATIENT'S BOWEL WAS INJURED. ACCORDING TO THE INITIAL REPORTER, THE INSTRUMENTS WERE INSTALLED IN THE PATIENT WITH THE SURGEON AT THE PATIENT SIDE CONSOLE (PSC) UNDER SCOPE VISUALIZATION. WHEN THE SURGEON SAT DOWN AT THE SURGEON SIDE CONSOLE (SSC), SHE WAS UNABLE TO SEE THE SCISSORS INSTALLED ON PATIENT SIDE MANIPULATOR (PSM1) 1. THE SURGEON MOVED THE CAMERA TO LOOK FOR THE SCISSOR TIPS. THE INITIAL REPORTER INDICATED THAT THE SURGEON FOUND THAT THE SCISSORS HAD NICKED/PUNCTURED THE PATIENT'S BOWEL. THE INITIAL REPORTER ALSO INDICATED THAT THEY WERE COMPLETING THE DA VINCI SURGICAL PROCEDURE AND ANOTHER SURGEON WAS GOING TO PERFORM THE BOWEL REPAIR USING THE DA VINCI SYSTEM. AT AN UNSPECIFIED TIME DURING THE EVENT, THE SURGICAL STAFF NOTICED THAT THE CANNULA ON PSM1 HAD BECOME DISCONNECTED." }, { "mdr_text_key": "17092763", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PSM WAS RETURNED TO ISI AND EVALUATED. THE LINK 6 BASE PLATE OF THE PSM WAS FOUND TO BE BENT AND RUBBING WHICH WAS CAUSING THE INSTRUMENT NOT TO SEAT PROPERLY. THE DAMAGE TO AXES 5 AND 6 AFFECTED THE INPUT DISCS THAT CONTROL THE OPENING AND CLOSING OF THE INSTRUMENT JAWS. THIS DAMAGE COULD HAVE IMPACTED INSTRUMENT INSTALLATION, POTENTIALLY CAUSING THE JAWS TO OPEN. DURING NORMAL INSTALLATION, THE INSTRUMENT JAWS DO NOT OPEN. IF THE PSM WAS THEN LEFT IN CLUTCH MODE BY THE OR STAFF, THE PSM WAS THEN FREE TO MOVE ABOUT WHILE THE BLADES OF THE MCS WERE EXPOSED; THE COMBINATION OF THESE FAILURES COULD HAVE ALLOWED FOR AN OPPORTUNITY FOR THE MCS TO NICK THE BOWEL. ON (B)(4) 2014, ISI CONTACTED THE SURGEON. THE SURGEON STATED THAT SHE INSTALLED THE INSTRUMENTS ON ALL ARMS WITH DIRECT VISUALIZATION. SHE INDICATED THAT WHEN INSTALLING THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT ON PSM1, SHE NOTICED THAT THE SCISSOR TIPS OPENED RIGHT AWAY. AFTER INSTALLING THE INSTRUMENTS, SHE WENT TO SIT DOWN AT THE SSC. WHEN SHE FIRST LOOKED FOR THE TIPS OF THE INSTRUMENTS, SHE NOTICED THAT THE TIPS OF THE MCS INSTRUMENT WERE NOT IN THE FIELD OF VIEW AS EXPECTED. WHILE LOOKING FOR TIPS OF THE MCS INSTRUMENT, SHE AS WELL AS 2 OTHER SURGICAL STAFF MEMBERS NOTICED THE PATIENT'S BOWEL MOVING. AT THAT TIME, SHE FOUND THE TIP OF THE MCS INSTRUMENT TOUCHING THE PATIENT'S BOWEL. AN APPROXIMATE 8MM SEROSAL TEAR WAS FOUND AT THE LOCATION OF WHERE THE MCS TIP WAS TOUCHING THE BOWEL. ANOTHER SURGEON WAS ABLE TO REPAIR THE BOWEL INJURY WITH SUTURES AND NO OTHER COMPLICATIONS WERE REPORTED. THE SURGEON CLAIMED THAT PSM1 HAD MOVED ON ITS OWN WHICH CAUSED THE BOWEL INJURY. THE SURGEON STATED THAT SHE DID NOT OBSERVE ANY ISSUES WITH THE CANNULA INVOLVED WITH THIS COMPLAINT. SHE WAS ALSO NOT AWARE THAT A PROBLEM WITH THE CANNULA WAS REPORTED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(4) 2014. NO SYSTEM ERRORS INVOLVING PSM1 WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED AN INJURED BOWEL DURING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." } ], "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": "" } ] }