The device was returned to olympus and evaluated.The customer¿s allegation was confirmed.The insertion tube inspection buckles, and the coating peels-off.Additional findings are as follows: (a.) due to a cut on the bending section cover, or distal sheath, water tightness is lost, (b.) the plastic distal end cover has a scratch, (c.) the adhesive on the bending section cover, or distal sheath has a crack, (d.) due to wear of angle wire, bending angle in up direction does not meet the standard value, (e.) the control unit has a scratch, (f.) the scope cover has a scratch, (g.) the grip has a scratch, (h.) the up down plate has a scratch, (i.) the angulation lever has a scratch, (j.) the switch box has a scratch, (k.) the light guide connector has a scratch, (l.) the video connector has a scratch, (m.) the video connector case has a scratch, (n.) and the protector of the video cable section has a scratch.A definitive root cause for this issue was not established.However, it is probable that the issue resulted from physical or chemical stress.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿important information ¿ please read before use: warnings and cautions: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ furthermore, the reprocessing manual indicates the following: ¿¿ store the endoscope and accessories in an endoscope storage cabinet that also protects the equipment from physical damage.¿ to prevent damage, do not store the endoscope and/or accessories in direct sunlight, at high temperatures, in high humidity, or exposed to x-rays, ultraviolet rays, or ozone.¿ to prevent damage, do not store the endoscope and/or accessories with chemicals or in a gas-generating area.¿ do not coil the endoscope¿s insertion tube or universal cord with a diameter of less than 12 cm.Such improper storage may damage the endoscope.¿ olympus will continue to monitor field performance for this device.
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