The device was evaluated by olympus.The evaluation found that the allegation was confirmed.Additional issues were identified during the device evaluation: insufficient angle; distal sheath was creased; insertion tube collapse, with scratches and wrinkles; universal cord was crushed and scratched, video cable crushed and scratched; chipping of distal sheath; video connector, video connector case, light guide connector scratch, light guide cover glass scratch; video connector contact peeling; operation part scratch, switch box scratch, grip scratch, angle lever scratch, up/down plate scratch, up/down angle fixing lever scratch; operation part index peeling, switch-box paint peeling, up/down plate paint peeling; and poor water tightness at the tip.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely that the handling of the device caused shaving of the forceps plug cap.A final root cause of this event was unable to be identified.The event can be prevented by following the instructions for use which state: ¿do not coil the insertion tube or universal cord with a diameter of less than 12 cm.Equipment damage can result.Do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged.Do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.Do not twist or bend the bending section with your hands.Equipment damage may result.The endoscope¿s remote switches cannot be removed from the control section.Pressing, pulling, or twisting them with excessive force can break the switches and/or cause water leaks.¿ olympus will continue to monitor field performance for this device.
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