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Catalog Number 6900727 |
Device Problem
Sharp Edges (4013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during an arthroscopy procedure, the mto refurb switching stick 3.6 ref 4308 was too skinny and it was too flexible, it was quite flimsy and sharp.The procedure was completed with a backup device with no delay nor patient injury.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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