{ "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": "2955842-2014-01844", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140331", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140228", "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": "20140331", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "191345", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140331", "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": "", "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": [ "Unintended Movement" ], "reporter_state_code": "NE", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250822", "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": "20140331", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20140228", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3710778", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140228", "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": "20485452", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text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}, { "mdr_text_key": "20101977", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI ENDOMETRIOSIS RESECTION PROCEDURE, PATIENT SIDE MANIPULATOR 3 (PSM3) HAD UNINTENDED MOVEMENT AND THE PATIENT WAS FOUND TO HAVE SUSTAINED TWO 1 PUNCTURE WOUNDS TO THE SIGMOID COLON. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON STATED THAT THE CLUTCH BUTTON FROM PSM3 HAD BEEN PUSHED TO MOVE THE INSTRUMENT TO THE END OF THE CANNULA TIP. AT THE TIME OF THE EVENT, IT IS UNCLEAR WHAT INSTRUMENT WAS INSTALLED ON PSM3. AT AN UNSPECIFIED TIME DURING THE SURGICAL PROCEDURE, THE SURGEON STATED THAT PSM3 WENT SPASTIC. THE SURGEON THEN REMOVED THE INSTRUMENT INSTALLED ON PSM3 AND FOUND TWO PUNCTURE WOUNDS TO THE SIGMOID COLON. THE SURGEON REPAIRED THE PUNCTURE WOUNDS AND INDICATED THAT THE PATIENT WAS DOING WELL. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE TEST DROVE THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. HE WAS UNABLE TO REPLICATE THE REPORTED ISSUE WITH PSM3. ON (B)(4) 2014, ISI CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON PROVIDED THE FOLLOWING INFORMATION: AN UNSPECIFIED NEEDLE DRIVER INSTRUMENT WAS INSTALLED ON PSM1, A PROGRASP FORCEPS INSTRUMENT WAS INSTALLED ON PSM2, AND GRASPING RETRACTOR INSTRUMENT WAS INSTALLED ON PSM3. WHEN THE BOWEL INJURIES OCCURRED, THE SURGEON INDICATED THAT HE HAD THE CAMERA CLUTCHED IN UP CLOSE TO THE AREA BETWEEN THE BLADDER AND CERVIX. THE SURGEON HAD RESECTED SOME ENDOMETRIOSIS AND WAS GETTING READY TO SUTURE THE DEFECT IN THE PERITONEUM. PSM1 AND PSM2 WERE CLEARLY IN VIEW ON THE CONSOLE AND PSM3 WAS REPORTEDLY PARKED OVER ON THE RIGHT SIDE TOWARDS THE PATIENT'S APPENDIX. AS THE SURGEON WAS MOVING PSM1 AND PSM2 SLIGHTLY AND CLUTCHING THE CAMERA IN AND OUT, THE SURGEON BECAME AWARE OF RESISTANCE AND A SMALL DEGREE OF SHAKING OF THE CAMERA. THE SURGEON INDICATED THAT IT FELT AS IF THERE WAS A COLLISION OF THE PSM'S. THE BEDSIDE ASSISTANT ALERTED THE SURGEON THAT THERE WAS AN ISSUE. THE SURGEON THEN PULLED BACK WITH THE CAMERA AND FOUND THAT THE PREVIOUSLY PARKED PSM3 HAD IT'S TIP STICKING INTO THE BOWEL AT THE RECTOSIGMOID JUNCTION AS IF IT HAD SUDDENLY SNAPPED BACK INTO POSITION. THERE WAS NO SPILLAGE OF BOWEL CONTENT. THE BOWEL WAS SEWN OVER. THE PATIENT REPORTEDLY DID WELL AND WAS DISCHARGED. ACCORDING TO THE BEDSIDE ASSISTANT, PSM3 HAD DONE A LOT OF SHAKING AS IT SNAPPED INTO POSITION. THE SURGEON INDICATED THAT THE PATIENT WAS DOING WELL AT THIS TIME." } ], "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": "" } ] }