Catalog Number 24-5431 |
Device Problem
Component Missing (2306)
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Patient Problem
No Information (3190)
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Event Date 09/07/2017 |
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.
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Event Description
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As reported by the distributor, a 10-pk of surgery strips contained 9.
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Manufacturer Narrative
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The corrective action was to check the manufacturing documentation for this lot and perform a tcr for all the operators associated with the lot under question.The manufacturing documentation was pulled and reviewed.Nothing was found to be out of the ordinary with this work order.Root cause is likely due to operator error, this however could not be determined.Per the requirements of the specification the operator is required to inspect the front and back of each strip and count the stack.The operator than weighs the stack to make sure there are 10 strips prior to bagging the stack.A tcr and ilc were opened to retrain all the operators that had worked on this product and lot #.
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Event Description
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As reported by the distributor, a 10-pk of surgery strips contained 9.No reported patient harm or delay reported.
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Manufacturer Narrative
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The corrective action was to check the manufacturing documentation for this lot and perform a tcr for all the operators associated with the lot under question.The manufacturing documentation was pulled and reviewed.Nothing was found to be out of the ordinary with this work order.Root cause is likely due to operator error, this however could not be determined.Per the requirements of the specification the operator is required to inspect the front and back of each strip and count the stack.The operator than weighs the stack to make sure there are 10 strips prior to bagging the stack.A tcr and ilc were opened to retrain all the operators that had worked on this product and lot #.
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Event Description
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As reported by the distributor, a 10-pk of surgery strips contained 9.No reported patient harm or delay reported.
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Search Alerts/Recalls
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