{ "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": "I", "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": "2955842-2019-10249", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20190404", "manufacturer_address_2": "", "pma_pmn_number": "K152421", "date_of_event": "20190308", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20190404", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "275052", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190404", "brand_name": "DA VINCI", "generic_name": "CURVED-TIP STAPLER 30", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "470530-05", "catalog_number": "", "lot_number": "T10180522 0022", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20190313", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00886874112717", "udi_public": "(01)00886874112717(10)T10180522", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Difficult to Open or Close", "Difficult to Open or Close" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/11/2019;11/14/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20190404", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "71 YR", "patient_sex": "", "patient_weight": "71", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20190308", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8483335", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190308", "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": "140927505", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE CURVED-TIP STAPLER 30 INSTRUMENT WAS RETURNED FOR EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE A WHITE STAPLER 30 RELOAD STUCK IN IT. THE INSTRUMENT WAS ALSO FOUND TO HAVE A BROKEN GRIP CABLE AT THE PROXIMAL END (THE HOUSING). NO FRAGMENTS WERE FOUND TO BE MISSING. IN ADDITION, THE CURVED-TIP STAPLER 30 INSTRUMENT WAS RETURNED WITH A STAPLER SHEATH. NO TEARS OR DAMAGE WAS OBSERVED ON THE STAPLER SHEATH OTHER THAN NORMAL WEAR AND USAGE. THE SRK WAS ALSO RETURNED TO ISI AND EVALUATED. A VISUAL INSPECTION OF THE SRK FOUND NO DAMAGE. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2019. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THE SYSTEM LOGS REVEAL THAT THE CURVED-TIP STAPLER 30 INSTRUMENT SUCCESSFULLY CLAMPED, FIRED, AND UNCLAMPED WITH ONE WHITE STAPLER 30 RELOAD INSTALLED. THE USER MANUAL STATES, \"WHEN UNCLAMPED, MATCH GRIPS TO ENTER FOLLOWING MODE AND TAKE CONTROL OF THE INSTRUMENT AGAIN.\" CONSIDERING THE SYSTEM LOGS SHOW THAT THE CURVED-TIP STAPLER 30 INSTRUMENT SUCCESSFULLY UNCLAMPED, IT IS UNCLEAR AS TO HOW THE INSTRUMENT ALLEGEDLY GOT STUCK WHILE CLAMPED DOWN ON TISSUE. IT IS ALSO UNCLEAR AS TO WHY THE SURGICAL STAFF WAS UNABLE TO OPEN THE JAWS OF THE CURVED-TIP STAPLER 30 INSTRUMENT USING THE SRK WHICH IS RECOMMENDED TO BE USED WHEN THE JAWS DO NOT UNCLAMP NORMALLY. THE USER MANUAL ALSO STATES: \"WARNING: IF THE STAPLER RELEASE KIT DOES NOT RELEASE THE INSTRUMENT FROM TISSUE, ALTERNATE SURGICAL INTERVENTION MAY BE REQUIRED.\". THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE, THE INITIAL REPORTER CLAIMED THAT THE JAWS OF THE CURVED-TIP STAPLER 30 INSTRUMENT GOT STUCK WHILE CLAMPED DOWN ON TISSUE. THE SURGICAL STAFF USED A TRADITIONAL LAPAROSCOPIC STAPLER INSTRUMENT TO REMOVE THE CURVED-TIP STAPLER 30 INSTRUMENT. ¿EXTRA¿ TISSUE STUCK BETWEEN THE JAWS OF THE CURVED-TIP STAPLER 30 INSTRUMENT WAS REMOVED DURING THIS PROCESS WHICH WAS NOT ORIGINALLY INTENDED TO BE REMOVED AS PART OF THE SURGICAL PROCEDURE." }, { "mdr_text_key": "140927506", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE, THE JAWS OF A CURVED-TIP STAPLER 30 INSTRUMENT ALLEGEDLY GOT STUCK ON TISSUE. THE SURGICAL STAFF ATTEMPTED UNSUCCESSFULLY TO OPEN THE JAWS OF THE CURVED-TIP STAPLER 30 INSTRUMENT USING A STAPLER RELEASE KIT (SRK). THE SURGICAL STAFF ENDED UP USING A TRADITIONAL LAPAROSCOPIC STAPLER INSTRUMENT TO REMOVE THE ROBOTIC STAPLER INSTRUMENT. THERE WAS NO REPORT OF A PATIENT INJURY BY THE INITIAL REPORTER. ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: A 3RD-PARTY INSTRUMENT WAS USED LAPAROSCOPICALLY TO REMOVE THE CURVED-TIP STAPLER 30 INSTRUMENT AND THE SURGERY WAS COMPLETED WITH NO REPORTED INJURY TO THE PATIENT. \"EXTRA TISSUE\" WAS REPORTEDLY REMOVED DURING THE PROCESS OF RETRIEVING THE ROBOTIC STAPLER INSTRUMENT. THE ROBOTICS COORDINATOR EXPLAINED THAT TISSUE WITHIN THE CLAMPED JAWS OF THE CURVED-TIP STAPLER 3 WAS REMOVED. THERE WAS NO REPORTED EXTRA BLEEDING AS A RESULT. THERE HAVE BEEN NO REPORTS OF INJURY/HARM TO PATIENT POST-OPERATIVELY. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE STAPLER REMOVAL KIT (SRK) AS IT DID NOT OPEN THE JAWS MANUALLY. IT WAS REPORTED THAT THE SURGERY HAD BEEN GOING ON FOR A WHILE AND THE CURVED-TIP STAPLER 30 INSTRUMENT HAD BEEN USED 3 TIMES DURING THE CASE AND BEFORE THE EVENT OCCURRED. DURING THE 4TH ATTEMPT TO USE THE STAPLER INSTRUMENT, THE JAWS OF THE INSTRUMENT ALLEGEDLY LOCKED ON LUNG TISSUE. THE EMERGENCY STOP BUTTON WAS PRESSED ON THE SURGEON SIDE CONSOLE (SSC) AND THE SURGICAL STAFF TRIED TO UNCLAMP THE STAPLER JAWS. THERE WERE NO REPORTED OBSTRUCTIONS OR BUNCHING OF TISSUE. THERE WERE NO REPORTS OF ERROR MESSAGES. UPON INSPECTION OF THE CURVED-TIP STAPLER 30 INSTRUMENT, A BROKEN WIRE WAS IDENTIFIED." }, { "mdr_text_key": "309572730", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IN RELATION TO THE REPORTED EVENT, ON 11/14/2019, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A MDR (PATIENT IDENTIFIER (B)(6)) FROM A RISK MANAGER AT THE SITE WITH THE FOLLOWING EVENT DESCRIPTION: ¿THE STAPLER FIRED CORRECTLY BUT DIDN¿T RELEASE. A CONVENTIONAL STAPLER WAS USED TO CLAMP ABOVE THE STAPLE LINE TO FREE THE MALFUNCTIONING STAPLER. A WIRE WAS FOUND PROTRUDING FROM WRIST OF DEVICE.¿" }, { "mdr_text_key": "310792763", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RE-EVALUATED THE STAPLER RELEASE KIT (SRK). PHOTOS OF THE SRK REVEAL THAT THE TIP OF THE SRK WAS BROKEN OFF. A TWIST IN THE SRK IS OBSERVED PROXIMAL TO THE FRACTURE SURFACE, WHICH IS INDICATIVE OF EXCESSIVE TORQUE APPLIED TO THE SRK. THE DAMAGE WAS LIKELY A RESULT OF MISUSE, SUCH AS CONTINUING TO TURN THE TOOL ONCE IT HAD REACHED A HARDSTOP ON THE INSTRUMENT. THE WHITE STAPLER 30 RELOAD (PART #48630W-02; LOT #M10180607-0033) THAT WAS RETURNED WITH THE CURVED-TIP STAPLER 30 INSTRUMENT WAS ALSO EVALUATED. THE STAPLER RELOAD APPEARED TO BE USED AND FIRED. THE CARTRIDGE WAS OPENED AND THE STAPLER RELOAD WAS FOUND TO HAVE BLADE DAMAGE. NO LEAD SCREW DAMAGE WAS OBSERVED." } ], "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": "08/09/2019;12/06/2019" } ] }