ASPIRATION NEEDLE

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

Description of Event or Problem

ON MAY 17, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "BACTERIAL PERICARDITIS ACCOMPANIED BY SUDDEN CARDIAC TAMPONADE AFTER TRANSBRONCHIAL NEEDLE ASPIRATION CYTOLOGY". THIS STUDY WAS CONDUCTED ON THE TRANSBRONCHIAL NEEDLE ASPIRATION CYTOLOGY (TBAC) FOR A (B)(6)-YEAR-OLD MAN WITH PULMONARY LESIONS. IN THE LITERATURE, IT WAS REPORTED CARDIAC TAMPONADE, BACTERIAL PERICARDITIS, DEATH, AND AS FOLLOWS; AT THE AGE OF (B)(6), THE PATIENT HAD TOTAL CYSTECTOMY FOR BLADDER CANCER AND WIDE LOCAL EXCISION FOR MALIGNANT MELANOMA. THE PATIENT WAS A CURRENT SMOKER. THE PATIENT NOTICED OCCASIONAL CHEST PAIN AND DRY COUGH 1 MONTH BEFORE ADMISSION. WITH BRONCHOSCOPY, A TRANSBRONCHIAL BIOPSY OF THE TUMOR WAS PERFORMED AT THE ENTRANCE OF THE INFERIOR LINGULAR SEGMENTAL BRONCHUS DIRECTLY, AND TBAC WAS PERFORMED AT LYMPH NODE #7 BY A 21G AND 13-MM-LENGTH NEEDLE (BF TYPE 260, NA-2C). A HISTOLOGIC EXAMINATION REVEALED SMALL CELL CARCINOMA. THE PATIENT WAS ADMITTED 15 DAYS AFTER BRONCHOSCOPY FOR TREATMENT OF LUNG CANCER. ON THE NIGHT OF ADMISSION, BLOOD PRESSURE DECREASED AND THE PATIENT WAS THOUGHT TO BE IN A STATE OF CARDIAC TAMPONADE. THE DOCTOR PERFORMED PERICARDIAL DRAINAGE AND PURULENT PERICARDIAL EFFUSION WAS DISCHARGED. WITH THE DIAGNOSIS OF BACTERIAL PERICARDITIS, WE CONTINUED THE ADMINISTRATION OF ANTIBIOTICS AND THE DRAINAGE OF PERICARDIAL EFFUSION. THE CULTURE FOR BACTERIA SHOWED STREPTOCOCCUS CONSTELLATUS; HOWEVER, CYTOLOGY WAS NEGATIVE. BLOOD CULTURE WAS ALSO NEGATIVE. ALTHOUGH THERE WAS NO FINDING OF MEDIASTINITIS IN A CHEST COMPUTED TOMOGRAPHY SCAN, TBAC TO THE MEDIASTINAL LYMPH NODE MIGHT HAVE CAUSED BACTERIAL PERICARDITIS. CHEMOTHERAPY WAS COMMENCED AFTER 5 DAYS OF ANTIBIOTIC TREATMENT. HOWEVER, DESPITE CONTINUING ADMINISTRATION OF ANTIBIOTICS AND CHEMOTHERAPY, PERICARDIAL EFFUSION GRADUALLY INCREASED AGAIN, NECESSITATING SECOND PERICARDIAL DRAINAGE AFTER 19 DAYS OF ANTIBIOTIC TREATMENT. AFTER DRAINAGE, THE CULTURE FOR BACTERIA WAS NEGATIVE, AND CYTOLOGY SHOWED SMALL CELL CARCINOMA. ANOTHER CHEMOTHERAPY AND PALLIATIVE RADIOTHERAPY WERE THEN ADDED, RESULTING IN A LITTLE EFFECT. DESPITE ALL THESE EFFORTS, HIS DISEASE BECAME WORSE, AND THE PATIENT DIED 4 MONTHS LATER AFTER THE INITIAL REFERRAL. OMSC ASSUMES THAT THE BACTERIAL PERICARDITIS AFTER TBAC WAS A SERIOUS ADVERSE EVENT TO SUBMIT. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE WAS NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORTS (MDR) OF THE SUBJECT DEVICE FOR THE ADVERSE EVENT NEED FOR BACTERIAL PERICARDITIS.