{ "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": "2955842-2016-00262", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20160421", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160219", "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 REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160421", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "250649", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160421", "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 A60P9B", "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": [ "Loss of or Failure to Bond" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20160421", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Anemia", "Hemorrhage/Blood Loss/Bleeding", "Abdominal Distention", "Anemia", "Hemorrhage/Blood Loss/Bleeding", "Abdominal Distention" ] } ], "distributor_city": "", "date_report": "20160322", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5593987", "removal_correction_number": "", "number_devices_in_event": "", "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": "43200853", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THE SYSTEM LOGS REVEAL THAT THE SURGEON USED 2 SMALL CLIP APPLIER INSTRUMENTS (PART 420003) AND 2 MEDIUM-LARGE CLIP APPLIER INSTRUMENTS (PART 420327) DURING THE SURGICAL PROCEDURE. THREE OF THE FOUR CLIP APPLIER INSTRUMENTS WERE USED IN SUBSEQUENT SURGICAL PROCEDURES WITH NO REPORTED ISSUES. AT THE TIME THE SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2016, ONE OF THE MEDIUM-LARGE CLIP APPLIERS WAS USED FOR A FINAL TIME WITH ZERO USES REMAINING. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO REPORTED ISSUES WITH ANY OF THE FOUR CLIP APPLIER INSTRUMENTS USED DURING THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2016. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED INTERNAL POST-OPERATIVE BLEEDING THAT REQUIRED MEDICAL INTERVENTION. THE SURGEON CLAIMED THAT BLEEDING WAS A RESULT OF A CLOSED HEM-O-LOK CLIP THAT WAS COMING OFF OF A LINEAL ARTERY. HOWEVER, THE REASON AS TO WHY THE HEM-O-LOK CLIP WAS COMING OFF IS UNKNOWN. THERE WAS NO ALLEGATION THAT MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "43200854", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 6 HOURS AFTER COMPLETION OF A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED INTRA-OPERATIVE BLEEDING. THE PATIENT'S BLOOD PRESSURE DROPPED TO APPROXIMATELY 50 MMHG POST-OPERATIVELY. THE PATIENT'S HEMOGLOBIN LEVEL ALSO REPORTEDLY DROPPED TO 9.7 G/DL. BEFORE THE PROCEDURE BEGAN, THE PATIENT'S HEMOGLOBIN WAS 12.9 G/DL. DURING THE PROCEDURE, HIS HEMOGLOBIN LEVEL WAS 9.8 G/DL. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ACCORDING TO THE INITIAL REPORTER, THE PROGRESSION OF ANEMIA WAS NOT APPARENT AND THE PATIENT HAD LIGHTLY BLOODY DRAINAGE FROM AN UNSPECIFIED SOURCE. NO APPARENT ASCITES WAS FOUND VIA ULTRASOUND IN THE ABDOMINAL AREA. AFTER TRANSFUSIONS WERE ADMINISTERED, THE PATIENT'S BLOOD PRESSURE RECOVERED TO 80 MMHG. THE PATIENT'S RESPONSE WAS REPORTEDLY STILL POOR AND ABDOMINAL DISTENSION WAS NOTED. IN ADDITION, HIS DRAINAGE WAS NOTED TO BE BLOODY. THE PATIENT WAS THEN TAKEN BACK TO THE OR SINCE ABDOMINAL BLEEDING WAS IDENTIFIED. PRIOR TO THE START OF AN EMERGENCY OPERATION, THE PATIENT'S HEMOGLOBIN LEVEL WAS AT 6.7 G/DL. FRESH BLOOD AND BLOOD CLOTS IN THE INTRAPERITONEAL AREA WERE FOUND LAPAROSCOPICALLY. THE BLOOD WAS SUCTIONED UNTIL THE SURGICAL VIEW WAS CLEAR. THE TAIL OF THE PANCREAS WAS FOUND TO BE BLEEDING. THE SURGEON GRASPED THE PANCREAS TAIL WITH FORCEPS AND HEMOSTASIS WAS ACHIEVED. THE AREA AROUND THE PANCREAS TAIL WAS SUCTIONED. AT THAT POINT, THE SURGEON NOTICED THAT A HEM-O-LOK CLIP WAS COMING OFF THE STUMP PART OF THE LINEAL ARTERY. THE SURGEON DETERMINED THAT IT WAS TOO DIFFICULT TO PLACE ANOTHER CLIP ON THE SAME AREA WHERE THE HEM-O-LOK CLIP WAS COMING OFF. THEREFORE, THE SURGEON MADE THE DECISION TO CUT A PART OF THE PANCREAS TAIL USING AN END GIA TRI-STAPLE BLACK 60 INSTRUMENT. AFTER VERIFYING THAT THERE WAS NO OTHER BLEEDING AND THE INTRAPERITONEAL AREA WAS SUCTIONED FREE OF BLOOD, THE PATIENT'S WOUND WAS CLOSED. THE ESTIMATED BLOOD LOSS FROM THE EMERGENCY OPERATION WAS 3200G. HE WAS INTUBATED AND TAKEN TO THE ICU POST-OPERATIVELY. ON POST-OPERATIVE DAY 1, THE INTUBATION WAS REMOVED AND THE PATIENT WAS TAKEN TO THE GENERAL WARD. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. ACCORDING TO THE INITIAL REPORTER, THE DOCTOR COMMENTED THAT ALTHOUGH THE HEM-O-LOK CLIP WAS CLOSED, IT WAS COMING OFF AND THAT HAD ALLEGEDLY CAUSED THE BLEEDING. THE INITIAL REPORTER ALSO NOTED THAT THERE WAS NO ABNORMALITY WITH THE ROBOT'S FUNCTION DURING THE DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "63103208", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INITIAL MDR WAS SUBMITTED INCORRECTLY ON 04/21/2016 WITH A BLANK DATE RECEIVED BY MFR VALUE. THIS FOLLOW-UP MDR IS BEING SUBMITTED WITH A CORRECTED VALUE OF 03/22/2016." } ], "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": "12/21/2016" } ] }