{ "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. 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OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED." }, { "mdr_text_key": "189728195", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE \"THE THUNDERBEAT AND OTHER ENERGY DEVICES IN LAPAROSCOPIC COLORECTAL RESECTIONS: ANALYSIS OF OUTCOMES AND COSTS\". THE LITERATURE REPORTED THE RESULT OF 40 CASES OF THE LAPAROSCOPIC COLORECTAL RESECTION (LCR) PROCEDURES USING AN OLYMPUS MODEL THUNDERBEAT BETWEEN MARCH 2012 AND MARCH 2016. IN THE SUBJECT PROCEDURES, 1 CASE OF PNEUMONIA REPORTEDLY OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENT COULD NOT BE DETERMINED. 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