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Catalog Number 24-5431 |
Device Problem
Component Missing (2306)
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Patient Problem
No Information (3190)
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Event Date 07/13/2017 |
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 not available.
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Event Description
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As reported by (b)(6), a neuro strip 10 pack contained 8 strips.
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Manufacturer Narrative
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Manufacturing documentation was reviewed.Nothing was found to be out of the ordinary with this work order.Per the requirements of the specification the operator is required to count the amount of surgical strips and weigh the package with the strips to verify the count prior to sealing them in the package.Although we were unable to confirm the reported issue, retraining was performed with all the operators that had worked on this product and lot number.Based on the information provided, the cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.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.
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Search Alerts/Recalls
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