It was reported that, during surgery, the "set meniscus mender ii" was faulty.The loop retriever was disassembled between head and shaft when the package was opened.The procedure was successfully completed without delay using the remaining one of the two loop retrievers in the same package.No patient injuries or other complications were reported.
|
H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A corrective action for this failure mode is in place.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
|