Catalog Number 80-1403 |
Device Problem
Component Missing (2306)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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It is not clear at this point if the device is 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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Manufacturer Narrative
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Device was returned for evaluation.
A follow up report will be filed upon completion of the investigation.
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Manufacturer Narrative
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Upon completion of the investigation it was noted that the samples returned and visually inspected.
1 pattie was confirmed to be missing the string.
It appears to have but cut or sliced as the welded section of the string remained on the pattie.
The remaining 9 pattie samples were pull tested by a certified operator.
All samples passed and were measured between 2 and 5 lbs.
The manufacturing lot traveler was pulled and reviewed for lot h33029l-2.
All information on the traveler indicates that the product was produced within specifications.
There were no engineering change orders or anything unusual relative to the manufacturing documentation of this lot.
Based on the results of this investigation no further action is required.
Trends will be monitored for this and similar complaints.
At the present time this complaint is closed.
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Manufacturer Narrative
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Upon completion of the investigation it was noted that the samples returned and visually inspected.
1 pattie was confirmed to be missing the string.
It appears to have but cut or sliced as the welded section of the string remained on the pattie.
The remaining 9 pattie samples were pull tested by a certified operator.
All samples passed and were measured between 2 and 5 lbs.
The manufacturing lot traveler was pulled and reviewed for lot h33029l-2.
All information on the traveler indicates that the product was produced within specifications.
There were no engineering change orders or anything unusual relative to the manufacturing documentation of this lot.
Based on the results of this investigation no further action is required.
Trends will be monitored for this and similar complaints.
At the present time this complaint is closed.
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Manufacturer Narrative
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(b)(4).
Upon completion of the investigation, a follow up report will be filed.
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Event Description
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As reported by the ous affiliate, a surgical pattie did not have the green string attached.
No reported patient/user harm.
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Search Alerts/Recalls
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