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Catalog Number 7205335 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2019 |
Event Type
malfunction
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Event Description
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It was reported that during a surgery, the device had the right labelling outside the box and package but when the device was opened, the material was not the ones that they use.It was a different part of what the customer ordered.The device was used by error.A backup device was available to complete the procedure successfully.Delay or patient injuries were not reported.
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Manufacturer Narrative
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The device in question will not be returned for evaluation however, four unused full radius concave blades were returned for referenced complaint (b)(4).Visual assessment of the blade confirmed the reported complaint.The bend orientation (convex instead of concave) is incorrect.This error results in the cutting window being located incorrectly relative to the bend.
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Search Alerts/Recalls
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