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Catalog Number 26-1221 |
Device Problems
Device Issue (2379); Dull, Blunt (2407)
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Patient Problem
No Information (3190)
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Event Date 09/09/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Upon completion of the investigation, a follow up report will be filed.
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Event Description
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The perforator was not functioning because it was not cutting enough.There was no clinical consequence.Another perforator was used.
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Manufacturer Narrative
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Upon completion of the investigation it was noted that the customer¿s complaint of "perforator was not cutting enough" was not verified.This perforator met the test method acceptance requirements; proper engagement and disengagement were achieved with every drill hole.There was no erratic or poor cutting action.The device history records (perforator assembly) show all tests and inspections, including a drilling test on each perforator, met specification requirements.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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Search Alerts/Recalls
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