"during fragmentation of stone in lower pole calyx of kidney, a 200um fiber broke leaving segment of laser fiber in kidney.Segment of fiber was 5-6 cm long and needed to be retrieved with a basket.New fiber used and same thing happened.All laser fiber safely retrieved, but incomplete treatment of stone fragmentation.Stent placed and patient sent for eswl.No harm to patient." fiber 1 - took ten minutes to retrieve the fragments.Fiber 2 - took twenty minutes to retrieve the fragments.This event is for fiber 2.
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A lumenis technical engineer examined the power suite laser system one month after the event completing performance tests of all specifications and concluding the device operated to manufacturer's specifications.A review of the laser system and fiber's device history records (dhr) determined that the subject devices were manufactured and tested according to manufacture specifications.The fiber was returned to the manufacturer for testing and examination.A lumenis quality engineer examined the fiber and concluded that the "fiber was broken due to excessive bending or exceeding the fiber tensile strength during use.Visually, the fiber is broken and burned, appearing pinched or twisted which would cause the break".Most probable root cause for this event was determined to be a "use error".Although the doctor was able to remove the broken fiber fragments from the patients kidney and no patient harm had been reported, lumenis is reporting this event as medical intervention was required to preclude serious injury.Corrected data: although the initial report of this mdr indicated that a product problem/malfunction contributed to the adverse event, it was concluded that device malfunction is not suspected as the cause or contributory to the event reported.
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