Additional product code; gcj.
At time of filing, although expected, the reported device has not been returned to conmed for evaluation.
A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.
This issue will continue to be monitored through the complaint system to assure patient safety.
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Conmed (b)(4) received a report of issues with the 10k100, linvatec 10k / 24k arthroscopy inflow tubing set, lot 202010154.
It was reported that during proctology robotic surgery involving a (b)(6) female, white debris was found.
The white debris was removed using a suction.
The surgery was successfully completed without an alternative but with a 15minute delay.
It is indicated that there was no impact or injury to the patient.
This report is being raised on the basis of malfunction with potential for injury upon reoccurrence due to the unknown foreign debris which was removed.
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