Product evaluation: fiber analysis for 0010-2400-21911808-(b)(4): the glass cap shows a circumferential fracture on the distal side of fiber/cap fusion zone at the bevel edge; the fiber proximal to fracture can rotate independently of outer flow tubing; the glass cap exhibits severe devitrification at output window; the metal cap exhibits mild char on surface; the outer flow tubing open end exhibits minor scratch marks.Based on device analysis, the potential for forward firing may exist.Probable root cause: based on the device analysis, the probable root cause of the failure is: operational context.The probable root cause was determined based on heat accumulation.Cap wear was accelerated due to anatomical/procedural factors (tissue contact and technique) encountered during the procedure which would limit the performance of the fiber.
|
It was reported that during a benign prostatic hyperplasia (bph) surgical procedure at 289,871 joules of use and 55:02 minutes, the fiber was noted to be flexible into the sheath.The fiber tip was not cleaned during the procedure.The procedure was completed with a second fiber.No injury to the patient was reported.
|