{ "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": "2955842-2012-01401", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20121221", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121127", "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": [ "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20121221", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121221", "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 A60P7", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "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": "20121221", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Excessive Tear Production" ] } ], "distributor_city": "", "date_report": "20121127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2883607", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121127", "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": "15423541", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DAVINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGICAL STAFF WAS UNDOCKING THE SYSTEM FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUFFERED A BOWEL TEAR DURING THE PROCEDURE. ACCORDING TO THE INFORMATION PROVIDED BY INITIAL REPORTED CLINICAL SALES REPRESENTATIVE, THE TIPS OF THE PROGRASP FORCEPS INSTRUMENT WERE NOT USED TO GRAB THE BOWEL, BUT THE SHAFT OF THE INSTRUMENT WAS USED TO RETRACT THE BOWEL." }, { "mdr_text_key": "15688298", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ACCORDING TO THE INFORMATION PROVIDED BY THE CLINICAL SALES REPRESENTATIVE, THE GYN SURGEON (HE HAD PERFORMED 4-5 CASES) WAS PERFORMING A LENGTHY DVH. THERE WAS A BOWEL PERFORATION AND TEARS IN THE SEROSA OF THE SIGMOID COLON, WHICH WERE NOT NOTICED UNTIL THE ROBOTIC PORTION WAS COMPLETE AND THE SURGEON WAS READY TO UNDOCK THE DAVINCI ROBOT SYSTEM. THE CSR WAS IN THE OPERATING ROOM FOR MOST OF THE CASE AND DID NOT SEE A SPECIFIC CAUSE FOR THE INJURY. THE SURGEON WAS USING A PROGRASP FORCEPS INSTRUMENT TO PUSH/SWEEP THE BOWEL BACK WITH THE SHAFT/WRIST, BUT DID NOT GRAB BOWEL. THE ASSISTANT WAS BLINDLY INSERTING A LAP SUCTION/IRRIGATOR THROUGHOUT THE CASE. ONCE THE SURGEON NOTICED SOME UNUSUAL FLUID IN THE ABDOMEN AT THE END OF THE CASE, SHE CALLED A COLORECTAL SURGEON WHO REPAIRED THE BOWEL LAPAROSCOPICALLY. THE PATIENT RECOVERED WELL AND HAD NO FURTHER COMPLICATIONS. A REVIEW OF THE SYSTEM LOGS SHOWED NO SYSTEM MALFUNCTION OCCURRED DURING THE PROCEDURE PERFORMED ON (B)(6) 2012." } ], "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": "" } ] }