{ "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": "2026-05-12", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MS", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TUTTLINGEN,", "manufacturer_contact_address_1": "2151 E GRAND AVE", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "9610617-2024-00451", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241113", "manufacturer_address_2": "", "pma_pmn_number": "EXEMPT", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "90245", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "FAIR", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "78532", "manufacturer_g1_state": "", "reporter_country_code": "UK", "manufacturer_contact_area_code": "", "date_added": "20241113", "manufacturer_contact_f_name": "ANJA", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2313638", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20241113", "brand_name": "KARL STORZ AIDA", "generic_name": "KARL STORZ AIDA", "manufacturer_d_name": "KARL STORZ SE & CO. KG", "manufacturer_d_address_1": "DR.-KARL-STORZ-STRASSE 34", "manufacturer_d_address_2": "", "manufacturer_d_city": "TUTTLINGEN,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "78532", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "GM", "manufacturer_d_postal_code": "78532", "device_operator": "HEALTH PROFESSIONAL", "model_number": "WD300", "catalog_number": "WD300", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LMD", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Digital Image Communications, Radiological", "medical_specialty_description": "Radiology", "regulation_number": "892.2020", "device_class": "1" } } ], "product_problems": [ "No Display/Image", "Application Program Version or Upgrade Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/04/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250822", "health_professional": "Y", "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": "20241113", "sequence_number_treatment": [ "ARTICLE: TC304, SERIAL#: (B)(6)", " ARTICLE: TH120, SERIAL#: (B)(6)", " ARTICLE: WD300, SERIAL#: (B)(6)", " MODEL: TC201 - SERIAL# (B)(6)" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20241209", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "GM", "manufacturer_contact_city": "EL SEGUNDO", "mdr_report_key": "20676065", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20241028", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "78532", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "KARL STORZ SE & CO. KG", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "357533873", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT BOTH MONITORS ON A STACK LOST IMAGE WHILE BEING USED ON A PATIENT. NO INJURY OR NEGATIVE IMPACT IN STATE OF HEALTH WAS REPORTED." }, { "mdr_text_key": "357533874", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICES ARE STILL IN USE AT THE HOSPITAL AND NO DEVICES WILL BE RETURNED. AN INVESTIGATION WITHOUT THE AFFECTED DEVICES WILL BE CONDUCTED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4)." }, { "mdr_text_key": "361029151", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTION TO D SECTION FOR SUSPECTED DEVICE TO WD300 AND ADDING TC201 IN D10 CONCOMITANT MEDICAL PRODUCTS. DEVICE EVALUATION: THE INVOLVED DEVICES WERE NOT RETURNED TO THE MANUFACTURER BUT CHECKED IN THE FIELD BY A SERVICE TECHNICIAN. BASED ON THE FINDINGS FROM THE SERVICE TECHNICIAN, IT COULD BE DETERMINED THAT THE ISSUE LEADING TO THE REPORTED EVENT WAS NOT RELATED TO THE DEVICE TC201 (IMAGE1 S CONNECT II) AS INITIALLY SUSPECTED. IT WAS DETERMINED THAT IT IS RELATED TO THE DEVICE WD300 (KARL STORZ AIDA). THEREFORE, THE LEADING PRODUCT WAS CHANGED ACCORDINGLY TO DEVICE WD300 (SERIAL# (B)(6)) AND DEVICE TC201 IS CONSIDERED AS AN INVOLVED/ CONCOMITANT PRODUCT. THE CUSTOMERS FAILURE DESCRIPTION \"BOTH MONITORS ON THIS STACK LOST IMAGE\" COULD BE VERIFIED BY THE SERVICE TECHNICIAN. THE FAULT COULD BE REPLICATED AT LEAST PARTIALLY. BASED ON THE AVAILABLE INFORMATION, IT IS CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE WAS A SOFTWARE ISSUE WITH THE AIDA SOFTWARE VERSION 1.8.1 WHICH WAS INSTALLED AT THE TIME THE EVENT HAPPENED. AN UPDATE TO VERSION 1.8.2.2 WAS PROCEEDED TO IMPROVE THIS SITUATION. ADDITIONALLY, THE AIDA DISPLAY PORT LOOP THROUGH WAS REWIRED FOR A DIRECT SIGNAL TO MAIN SURGICAL MONITOR AND THE DVI BACKUP SIGNAL CABLE REPLACED AS A PREVENTATIVE MEASURE TO HAVE A FUNCTIONAL BACKUP LINE IN PLACE IF THE EVENT OCCURS AGAIN. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "DR.-KARL-STORZ-STRASSE 34", "distributor_zip_code": "", "manufacturer_contact_postal_code": "90245", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/09/2024" } ] }