Model Number CYF-V2R |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation and service.The evaluation confirmed that the device failed the leak test.Based on the visual inspection performed, the bending section cover was found torn at the middle section; no missing pieces.The distal end portion of the bending section was stretched over the tip.The large torn on the bending section cover caused the device to failed the air/water leakage test.The device was serviced and returned to the user facility.
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Event Description
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The user facility returned the device for evaluation and service due to the air/water leakage or fluid invasion issue.It was also reported that the bending section sheath of the bending section burst out, as the device was sterilized without attaching the safety cap.Olympus followed up with the user facility to obtain additional information and was informed that there was no patient involvement.No additional information was provided.
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Event Description
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Upon further review, this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Manufacturer Narrative
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Upon further review, this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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