Model Number 0748 |
Device Problem
Sharp Edges (4013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.1 device was functionally/visually inspected in the field; however, there was no product malfunction.The issue was the result of use error.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 2 malfunction events, where it was reported the devices experienced sharp metal edges.There was no patient involvement.
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Event Description
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This report summarizes 2 malfunction events, where it was reported the devices experienced sharp metal edges.There was no patient involvement.
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Manufacturer Narrative
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This supplemental is being filed to fix a results code following the completion of a device investigation.
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Search Alerts/Recalls
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