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Catalog Number 26-1221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Information (3190)
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Event Date 05/17/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.
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Event Description
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During pre-use testing, the disengagement function of the device did not work properly, so the device was not used for surgery.There were no adverse consequences associated with this event.
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Search Alerts/Recalls
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