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 the information, the following was concluded: the device was returned to service facility for evaluation.During evaluation, the reported issue of cord is pulling away at the strain relief was confirmed.Cord is pulling away, breaking at the strain relief exposing bare wires on the probe end.The root cause is due to use of the device.H3 other text : evaluation findings are in section h11.
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