Based on the returned product evaluation, this is no longer reportable for a product problem/malfunction.Blocks d9/g3: the intrasight touchscreen monitor was returned for evaluation.Block h3: visual inspection found a cracked screen with missing material, but no sharp edges were noted as determined by a glove test.Block h6: medical device problem code corrected from 4013 (sharp edges) to 1135 (crack) based on the returned product evaluation.The complaint codes listed in the initial mdr remain acceptable (10- type of investigation, 3252- investigation findings, and 61- investigation conclusion).The probable cause is likely damaged from use.The device integrity can be affected by external factors such as device manipulation, its impact, and applied pressure associated with use and handling.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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