Boston scientific concludes that the reported allegations in this complaint have not been confirmed, as the product was not returned for analysis.Without a returned device, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
|
It was reported that during a photoselective vaporization of the prostate procedure, the greenlight fiber showed a fiberlife message.Additionally, there was a diffuse beam suggesting a broken fiber tip.A new fiber was opened to complete the procedure.There were no patient complications.
|