The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of the strain relief separated from the probe housing was confirmed.The probe cable is separating from the strain relief which is exposing wires.Reported issue root cause: the root cause is use-related.
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