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: during evaluation, the reported damage cable was confirmed.Although the probe is functional, the cable was found to be damaged at the bottom of the strain relief.The damage was at the ziff end of the connector and wires were found to be exposed.There were also multiple cracks on the nose housing.The root cause of the probe damage was identified as use-related damage.The review of the dhr, sub-assembly dhr, sub-assembly manufacturing, component records, manufacturing process changes, mrr/mrb, and internal rejects showed that the reported issue is not likely related to a manufacturing issue.The probe was cleaned, tested, and determined to be not repairable.
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