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Catalog Number 26-1221 |
Device Problem
Plunge (1462)
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Patient Problem
Tissue Damage (2104)
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Event Date 12/19/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Root cause cannot be verified; the perforator was not returned.Evaluation will be performed when/if the perforator is eventually received.The device history records (dhr's) for this perforator (lot lj024s, w/o # (b)(4)) were reviewed.All tests and inspections associated with the assembly, (including a 100% functional drill test and manual functional tests) 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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Event Description
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(neuro coordinator) also mentioned that the same thing happened yesterday (the perforator plunged, tearing the dura) with the clinician.That perforator was not saved.
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Search Alerts/Recalls
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