Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that after the investigation was performed and while reviewing the case, the stated failure mode presented, it can be confirmed that the patient had no injury, nor potential injury due to this malfunction, additionally a backup device was used to finish the surgery, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
|