(b)(4).Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information received: a photo was received for review.Upon visual inspection of the photo, the photo shows a totally dissembled trocar from front view.Based on the photo, the event described is confirmed.However, no conclusion or root cause could be determined as the device has not been received for analysis.Hands-on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.
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