Catalog Number 6506000000 |
Device Problem
Sharp Edges (4013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
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.24 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.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 24 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.
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Manufacturer Narrative
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An additional event was identified and therefore added to this summary report.
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Event Description
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This report summarizes 25 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.
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Manufacturer Narrative
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Initially it was reported that there were 2 instances of this hazard/model number combination.Further review of records identified that one record was a duplicate.The number of occurrences summarized have been updated to reflect this.
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Event Description
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This report summarizes 24 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.
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Search Alerts/Recalls
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