H10 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.There was a relationship found between the subject device and the reported incident.An analysis of the customer provided image revealed that the meniscal loop had disconnected from the handle and had some bending, indicating that it was pulled out of the packaging by the loop or shaft.This device is intended to be opened by pushing the back of the plastic packaging to release the handle.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause was associated with device design.
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