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Model Number 797403 |
Device Problem
Sharp Edges (4013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This case was reviewed and investigated according to the manufacture¿s policy.The field service engineer (fse) has not yet visited the account to provide service, thus a supplemental report will be filed upon completion.Do not apply to this submission.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 during an ivus case, the intrasight''s system''s touchscreen monitor had a crack with sharp edges observed.There was no patient or 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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Block g3: date the fse investigation was closed.Blocks h3 & h6: in the initial mdr, it was noted that "device evaluation anticipated, but not yet begun".However, the account has not requested service to replace the monitor; therefore, after an extended period of inactivity, the fse investigation closed.No returned monitor to evaluate.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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Search Alerts/Recalls
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