{ "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": "2026-10-07", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "-439", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "North Haven", "manufacturer_contact_address_1": "8200 Coral Sea St NE", "manufacturer_contact_pcity": "+1(800)6", "event_type": "Injury", "report_number": "1219930-2026-04689", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260728", "manufacturer_address_2": "", "pma_pmn_number": "K250725", "date_of_event": "20260713", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "", "manufacturer_contact_plocal": "+1(800)646-4633", "noe_summarized": "1", "manufacturer_contact_l_name": "Bocchino", "source_type": [ "Foreign", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "06473", "manufacturer_g1_state": "CT", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260728", "manufacturer_contact_f_name": "Mike", "device_date_of_manufacturer": "20260601", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "635612", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260728", "brand_name": "Hugo¿ RAS System", "generic_name": "MODULAR ELECTROMECHANICAL SURGICAL SYSTEM", "manufacturer_d_name": "Covidien Surgical", "manufacturer_d_address_1": "60 Middletown Ave", "manufacturer_d_address_2": "", "manufacturer_d_city": "North Haven", "manufacturer_d_state": "CT", "manufacturer_d_zip_code": "06473", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "06473", "device_operator": "HEALTH PROFESSIONAL", "model_number": "MRASI0001", "catalog_number": "MRASI0001", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20260716", "device_report_product_code": "SCV", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10884521826694", "udi_public": "(01)10884521826694(11)260601(20)13", "openfda": { "device_name": "Modular Electromechanical Surgical System", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4964", "device_class": "2" } } ], "product_problems": [ "Break", "Device Fell" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/31/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260929", "health_professional": "N", "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": "20260728", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20260901", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Mounds View", "mdr_report_key": "50062871", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260713", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "06473", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "Covidien Surgical", "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": "15867566968", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "It was reported that, during a robotic laparoscopic radical prostatectomy procedure, the tip of the Monopolar Curved Shears (MCS) br oke off and fell into the patient¿s cavity. The team searched for the broken part using a magnet. An X-ray was not used because the team believed there was a high probability that the part had been removed by the suction device. The instrument was replaced with a new one." }, { "mdr_text_key": "16367566969", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B1: Adverse Event & Product Problem Preliminary Device Evaluation: Medtronic is leading an evaluation of the reported Monopolar Curved Shears (MCS). Review of the three provided images notes the first image shows the MCS with a missing tip on one of the instrument jaws. The second image shows the serial number of the instrument, which matches the reported information. The third image shows a lateral view of the MCS with the tip of one side of the jaw missing. Further evaluation of the reported Monopolar Curved Shears is still pending, and the investigation is not able to identify a root cause at this time. Additional information will be provided in a supplemental regulatory report when the investigation is complete. Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "60 Middletown Ave", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55112-4391", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/01/2026" } ] }