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Catalog Number 26-1221 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Information (3190)
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Event Date 01/04/2018 |
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.Device discarded.
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Event Description
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As reported by the ous affiliate a codman perforator didn't cut as expected.Another was used to complete the procedure.There were no reports of delay or patient harm.
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Manufacturer Narrative
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(b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing record found no discrepancies.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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