Catalog Number 6500000000 |
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.13 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is pending evaluation.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 14 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 14 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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The device pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Section h codes have been updated to reflect this.
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Search Alerts/Recalls
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