{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2020-10324", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200419", "manufacturer_address_2": "", "pma_pmn_number": "K173906", "date_of_event": "20200325", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Foreign", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20200419", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20190212", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "439329", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200419", "brand_name": "DA VINCI", "generic_name": "INSTRUMENT SHEATH", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "430012-14", "catalog_number": "430012", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200518", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Break", "Detachment of Device or Device Component", "Break", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/01/2020;03/26/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250806", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20200419", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200326", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "9975739", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200326", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315932667", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "4315 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT SHEATH INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. A VISUAL INSPECTION OF THE INSTRUMENT SHEATH WAS PERFORMED AND FOUND DAMAGE. THE DAMAGE MEASURED APPROXIMATELY 0.063\" X 0.076\". NO MATERIAL WAS MISSING. ADVANCED FAILURE ANALYSIS CONFIRMED THAT THE DISTAL END OF THE SHEATH WAS DAMAGED IN A FEW LOCATIONS. THE BLACK PELLETHANE SECTION EXHIBITED TEARING ROUGHLY 3\" FROM THE DISTAL TIP OF THE SHEATH. THERE WERE SCRATCHES NEAR THE PELLETHANE TO PEBAX INTERFACE, ROUGHLY BETWEEN 4\" AND 4.5\" FROM THE DISTAL TIP. TEARING AT AROUND 3\" COINCIDES CLOSELY WITH THE JOGGLE JOINT ELBOW WHERE THE SHEATH IS INSTALLED ON AN INSTRUMENT. WHEN THE ELBOW IS BENT, THE PELLETHANE MATERIAL IS EITHER STRETCHED OR BUNCHED AT THE ELBOW, AND BOTH OF THESE SCENARIOS WOULD BE MORE SUSCEPTIBLE TO TEARING THAN IF THE INSTRUMENT WAS STRAIGHT. THE SAME SITE RETURNED ANOTHER INSTRUMENT SHEATH AND A CAMERA SHEATH USED IN THE SAME CASE THAT BOTH EXHIBITED DAMAGE. TWO SINGLE PORT (SP) INSTRUMENTS WITH SHEATHS INSTALLED RUBBING TOGETHER ARE UNLIKELY TO CAUSE THE DAMAGE OBSERVED IN THE SHEATHS. HOWEVER, IT IS POSSIBLE THAT EXTERNAL COLLISIONS WITH OTHER LAPAROSCOPIC INSTRUMENTS CAUSED THE SHEATH DAMAGE, WHICH WOULD BE RELATED TO MISUSE. AT THIS TIME, THERE IS NOT ENOUGH INFORMATION TO CONCLUSIVELY IDENTIFY THIS AS THE ROOT CAUSE. THEREFORE THE CAUSE OF THE SHEATH DAMAGE REMAINS UNKNOWN. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE PROVIDED TO ISI FOR REVIEW. A SYSTEM LOG REVIEW WAS PERFORMED, BUT NO ERRORS RELATED TO THIS EVENT WOULD EXIST IN THE LOGS. REFER TO THE REPORTS WITH PATIENT IDENTIFIER (B)(6) FOR THE RELATED COMPLAINT FOR THE CAMERA SHEATH AND PATIENT IDENTIFIER (B)(6) FOR THE RELATED COMPLAINT FOR THE INSTRUMENT SHEATH #2. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND DAMAGE ON THE INSTRUMENT SHEATH AND CAMERA SHEATH AND FRAGMENTS FROM AN UNKNOWN SOURCE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AS OF THE DATE OF THIS REPORT, THE SOURCE OF THE DAMAGE TO THE INSTRUMENT SHEATH AND THE CAMERA SHEATH AS WELL AS THE SOURCE OF THE FRAGMENTS REMAINS UNKNOWN." }, { "mdr_text_key": "336070742", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED." }, { "mdr_text_key": "336070743", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "206565963", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS NOT YET RECEIVED THE INSTRUMENT SHEATH FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE PROVIDED TO ISI FOR REVIEW. A SYSTEM LOG REVIEW WAS PERFORMED, BUT NO ERRORS RELATED TO THIS EVENT WOULD EXIST IN THE LOGS. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND DAMAGE ON THE INSTRUMENT SHEATH AND CAMERA SHEATH AND FRAGMENTS FROM AN UNKNOWN SOURCE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AS OF THE DATE OF THIS REPORT, THE SOURCE OF THE DAMAGE TO THE INSTRUMENT SHEATH AND THE CAMERA SHEATH AS WELL AS THE SOURCE OF THE FRAGMENTS REMAINS UNKNOWN. REFER TO THE REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE RELATED COMPLAINT FOR THE CAMERA SHEATH." }, { "mdr_text_key": "206565964", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND DAMAGE ON THE INSTRUMENT SHEATH AND CAMERA SHEATH. FRAGMENTS FROM AN UNKNOWN SOURCE WERE IDENTIFIED AND RETRIEVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. BOTH THE CAMERA SHEATH AND INSTRUMENT SHEATH WERE IN USE FOR 30-40 MINUTES PRIOR TO THE ISSUE AND WERE INSPECTED PRIOR TO USE. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT SHEATH WAS FOUND TO BE SCRATCHED AFTER THE SURGERY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH FUNCTIONALITY DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT HEAR ANY SOUND OF INSTRUMENTS COLLIDING WITH ANOTHER DEVICE OR OTHER HARD MATERIAL, BUT HEARD A \"RELATED ERROR NOTIFICATION.\" THE FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED INTRAOPERATIVELY. THE WRIST WAS STRAIGHTENED UPON THE FINAL REMOVAL OF THE INSTRUMENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT AND SHEATH THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AND NO OTHER DAMAGE TO THE INSTRUMENT OR SHEATH UPON COMPLETION OF THE PROCEDURE. THE INSTRUMENT SHEATH AND CAMERA SHEATH ARE AVAILABLE FOR RETURN TO ISI. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/29/2020;05/24/2023" } ] }