This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation and as the device was not returned to olympus, root cause of the reported issue cannot be determined.It was presumed that the reported issue was most likely due to wrong handling / improper handling on the part of the user.Additionally, the user may have drawn the activated laser probe into the sheath or activated the laser probe in the sheath, which is contrary to the instruction for use.The event can be detected/prevented by following the instructions which states: note when the laser fiber¿s guiding pin within the adapter¿s narrow groove faces downwards, the laser beam will be emitted from the underside of the laser fiber.Caution risk of damaging the inner sheath the inner sheath¿s distal end may be damaged if the laser fiber¿s tip is retracted into the sheath too early.To minimize this risk, use the adapter wa22870a together with a compatible laser fiber.Danger risk of death or serious injury improper use of lasers can cause burns, eye damage, and explosions.Thoroughly review the laser safety information included in the system guide endoscopy.Olympus will continue to monitor field performance for this device.
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