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Catalog Number 26-1221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Attempts are being made to obtain additional information.Upon receipt of new relevant information, a follow-up report will be submitted.
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Event Description
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As reported via medwatch mw5080257, a perforator failed to disengage, reaching the tissue level.The nuerosurgeon examined the affected area and determined that there was no obvious damage.The perforator was taken off the field.
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Manufacturer Narrative
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Udi: (b)(4).It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
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Search Alerts/Recalls
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