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Model Number 797403 |
Device Problems
Crack (1135); Sharp Edges (4013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This case was reviewed and investigated according to the manufacturer¿s policy.At the customer site, a field service engineer replaced the intrasight system''s cracked touchscreen monitor and confirmed operation.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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Event Description
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It was reported that the intrasight system''s touchscreen monitor was cracked with possible sharp edges.There was no patient involvement.No user injury reported.This product problem is being reported in an abundance of caution because the touchscreen monitor was cracked with sharp edges that can result in a potential for harm.
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Manufacturer Narrative
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B1/b5/h1: based on the returned product evaluation, this is no longer reportable for a product problem.There is no potential for harm for cracks, unless a sharp edge is confirmed.D9/g3: the intrasight touchscreen monitor was returned for evaluation.H3: visual inspection found a cracked screen, but no sharp edges were noted as determined by a glove test.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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Event Description
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This product problem is no longer reportable because no sharp edges were observed during the returned product evaluation.
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Search Alerts/Recalls
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