It was reported that during procedure, outside the patient, the set meniscus mender ii disposable the loop retriever was disassembled between head and shaft when the package was opened.No surgical delay.It is unknown how the procedure was finished.Patient injuries were not reported.
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H3, h6 the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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 visual inspection revealed that one meniscal suture loop was detached from the handle and the other remained intact.The complaint was confirmed, and the root cause was associated with device design.
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