Sorin group received a report of multiple occurrences where the camera and scope slipped out of the optical dissector during a vessel harvesting procedure.It was also reported that each occurrence resulted in damage only to the vessel being harvested.There was no report of injury to the patient.A sorin group procedural specialist was dispatched to the facility to investigate.While at the facility, the procedural specialist learned that the facility had recently started using a new endoscope with a 1cm longer shaft than the endoscope used previously.The specialist indicated that the new scope did not seem to seat fully into the optical dissector when inserted.Two vascuclear optical dissectors were returned to sorin group usa for further investigation and an additional unit from lot 1330100181 was pulled from inventory for comparison.A visual inspection and functional evaluation of the returned unit and the unit from inventory, including a removal force test, revealed that the force required to remove an endoscope with a 30cm shaft was significantly lower than that for an endoscope with a 29cm shaft.A review of the validation documentation for this device found that all qualifications pertaining to the device's ability to retain the endoscope were performed using a fixture with a shaft length of approximately 29.3cm.The instructions for use for this device had previously indicated that the instrument was compatible with a shaft length of 290mm to 300mm.As a correction, the ifu has been updated to indicate that the device is only compatible with a shaft length of 290+/- 3mm.A capa (b)(4) has also been initiated at sorin group usa to confirm the root cause of this issue.
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