Model Number URF-P6 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to omsc.Omsc reviewed the manufacturing history of the device and confirmed no irregularity.When the olympus staff confirmed the device, foggy of the endoscopic image was found.It was also found that air leakage occurred at the distal end of the device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that the endoscopic image of the subject device became foggy during a therapeutic procedure.The device was replaced with similar endoscope and the procedure was completed.There was no patient injury associated with this report.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the evaluation result for the subject device by olympus medical systems corp.(omsc).The device was returned to omsc for evaluation.The evaluation by omsc confirmed there was a corrosion at the air leakage part where the metal and the plastic parts of the distal end were fixed with glue.It is surmised that the corrosion might occur due to insufficient rinsing during reprocessing at the user facility.The foggy image possibly occurred due to moisture infiltrating into the inside of the device through the air leakage part.
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Search Alerts/Recalls
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