{ "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": "2955842-2014-05127", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140821", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140528", "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": "20140822", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "505016", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140821", "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": "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20140821", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose" ] } ], "distributor_city": "", "date_report": "20140725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4029190", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140821", "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": "4842142", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A DA VINCI SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED AN ANASTOMOTIC LEAK. NO OTHER INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT." }, { "mdr_text_key": "12264178", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE ANASTOMOTIC LEAK EXPERIENCED BY THE PATIENT. ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-OPERATIVE LEAK EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT REPORTEDLY EXPERIENCED AN ANASTOMOTIC LEAK. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT." }, { "mdr_text_key": "22146935", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 08/21/2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON WHO PERFORMED THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT UNDERWENT THE DA VINCI SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2014, THE PATIENT PRESENTED WITH SYMPTOMS OF A LEAK AT THE GI JUNCTION. THERE WAS NO ANASTOMOSIS. THE SURGEON INDICATED THAT ONLY A STAPLE LINE WAS CREATED USING GREEN RELOADS WITH THE ENDOWRIST STAPLER 45 INSTRUMENT AND ONLY INTRACORPOREAL TECHNIQUES WERE USED. THE SURGEON INDICATED THAT THE PATIENT UNDERWENT MULTIPLE LAPAROSCOPIC PROCEDURES, OPEN WASHOUTS, AND DRAINAGE PROCEDURES. THE PATIENT ALSO UNDERWENT MULTIPLE ATTEMPTS AT STENT PLACEMENT. THE SEQUENCE OF EVENTS IS AS FOLLOWS: (B)(6) -- LAPAROSCOPIC WASHOUT AND DRAINAGE, JEJUNOSTOMY TUBE (B)(6) -- ENDOSCOPIC STENT PLACEMENT BY THORACIC SURGERY (B)(6) -- SECOND STENT PLACEMENT BY THORACIC SURGERY (B)(6) --LAPAROSCOPIC WASHOUT AND REMOVAL OF J TUBE (B)(6) -- OPEN WASHOUT AND SMALL BOWEL RESECTION (J TUBE SITE NECROSED) (B)(6) -- VATS DECORTICATION OF LUNG (B)(6) -- REMOVAL OF STENT BY THORACIC SURGERY THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2014. THE SURGEON INDICATED THAT THE PATIENT WAS HOME AND BELIEVES SHE IS MOSTLY HEALED. ACCORDING TO THE SURGEON, THE PATIENT HAS A HISTORY OF PRE-DIABETES AND SUPER MORBID OBESITY. THE SURGEON INDICATED THAT HE BELIEVES THAT THE PATIENT'S DIFFICULT ANATOMY AND SUPER OBESITY MAY HAVE CAUSED THE POST-SURGICAL LEAK EXPERIENCED BY THE PATIENT. HOWEVER, HE INDICATED THAT HE ALSO WONDERS ABOUT THE DURABILITY OF THE ENDOWRIST GREEN RELOAD FOR USE ON THE LEAK PRONE AREA OF THE UPPER STOMACH SINCE THE GREEN RELOAD HAS TWO ROWS OF STAPLES COMPARED TO THREE ROWS OF STAPLES ON THE BLUE RELOAD OR OTHER LAPAROSCOPIC STAPLERS. THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THERE IS NO VIDEO RECORDING OF THE SURGICAL PROCEDURE. ON (B)(6) 2014, THE ISI CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SURGEON. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE CASE HAS GONE TO THE PEER REVIEW BOARD AT THE HOSPITAL. THE CSR ALSO INDICATED THAT THE SURGEON INFORMED HIM THAT HE (THE SURGEON) TOLD THE PEER REVIEW BOARD THAT HE MADE THE INCORRECT CLINICAL DECISION TO USE GREEN RELOADS DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, ISI CONTACTED THE CSR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR COULD NOT RECALL IF THE SURGEON PERFORMED AN ANASTOMOTIC LEAK TEST DURING THE DA VINCI SURGICAL PROCEDURE. THE CSR ALSO INDICATED THAT THE SURGEON DID NOT USE STAPLE LINE BUTTRESS MATERIAL DURING THE PROCEDURE. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION." } ], "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": "09/19/2014" } ] }