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Model Number DISSECTOR, 3.0MM X 7CM |
Device Problems
Break (1069); Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported on (b)(6) 2021 by a facility representative via sems that an ar-9300ds dissectors teeth are dulling and metal shavings are breaking off inside the patient.This was discovered during a case with no patient impact.
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Manufacturer Narrative
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Complaint confirmed.Visual inspection under magnification identified the presence of circumferential grooves worn into the inner diameter of the outer tube hood, as well as chipping along the outer diameter of the cutting window, consistent with sites of metal debris production.The cutting blades were noted to be intact, although tissue remnants were found caught within the blades.The cause remains undetermined, although a probable cause of the debris production can be attributed to prying/leveraging the device against bone and/or hard tissue during use.
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Search Alerts/Recalls
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