There was no device available for analysis; however, the reported complaint was confirmed by the media provided by the costumer.Media also showed that the fiber was burned.A device history record review confirmed the device met all manufacturing specifications, a risk review confirmed that the event is accounted for in the risk documentation, a labeling review was performed and ifu includes specific warnings/instructions related to "fiber beam blinking/flashing/pulsing, fiber cap/tip fiber rotates within metal cap, fiber cap/tip break, fiber stopped working".There is no indication that the device was not used in accordance with the ifu.Based on the information provided, all compiled information on this investigation determines that the most probable cause is unintended use error caused or contributed to event since the interaction between the user and device, or sample, caused or contributed to the error.
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It was reported that during a photoselective vaporization of the prostate (pvp) procedure to treat benign prostatic hyperplasia (bph), the fiber beam began to intermittently flicker, and the fiber tip was rotating inside the metal cap of the fiber.Upon removing the fiber, the glass cap had broken off.The fiber had stopped working.The fiber was checked, and was no longer working, so another fiber was used to complete the procedure.No patient complications were reported.
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