The device was returned to olympus for evaluation and the customer's allegation was confirmed, the device evaluation found that the bending section rubber was torn and metal was protruding.The investigation is ongoing, a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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The customer reported to olympus, the oes cystonephrofiberscope sheath was split open at the end and missing a piece.The issue was found during preparation for use, the intended therapeutic procedure was completed with a similar device.There were no reports of patient harm.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified.The event likely occurred due to incorrect handling by the user.The event can be detected/prevented by following the instructions for use which state: 1) " do not pull the universal cord and video cable during an examination.The light guide connector will be pulled out from the output socket of the light source and the endoscopic image will not be visible." 2) "do not coil the insertion tube, universal cord, or video cable with a diameter of less than 10 cm.Equipment damage may result." 3) "do not attempt to bend or twist the endoscope¿s insertion section with excessive force.The insertion section may be damaged." 4) "do not apply shock to the distal end of the insertion section, particularly the objective lens surface at the distal end.Visual abnormalities may result." 5) "if the endoscope is dropped or the distal end of the endoscope receives a hard impact, the endoscope may be damaged even if no visible damage of the lens on the distal end can be found.In this case, stop using the endoscope, and contact olympus." 6) "do not twist or bend the bending section with your hands.Equipment damage may result." 7) "do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks." 8) "do not put or press the video connector and light guide connector on the insertion section when transporting or reprocessing.The insertion section may be damaged." olympus will continue to monitor field performance for this device.
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