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 probe is out of alignment while using gel caps is unconfirmed.The device was serviced, tested, and returned to the customer a history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
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