Catalog Number 5111-00250-060 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the pin of a 2.5mm coupler was bent.This was identified during setup and the physician did not use it.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The actual sample was received for evaluation.A visual inspection was performed which observed signs of minor amounts of dried blood.No manipulation or attempted approximation marks are visible which is consistent with the complainant¿s statement that the coupler assembly was not used in a surgical process.Additional inspection shows that the pins were bent on both coupler rings.The reported condition was verified.The cause of the condition was not determined.No functional testing was performed for this complaint.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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