Model Number ENF-V3 |
Device Problem
Problem with Sterilization (1596)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation.During the evaluation, a small leak around the eto pin was found.A light scratch was found on pcb but no leak.No other issues were found during the inspection.If additional information is provided a supplemental report will be filed.
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Event Description
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A user facility reported that a laryngo-videoscope will not pass the sterrad machine sterilization process.No patient involvement or injuries were reported.No additional information has been obtained.
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Manufacturer Narrative
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The user facility provided additional information regarding the reported event.There was only one scope involved in the event.The user facility reported that the device is cleaned immediately after a procedure.The endoscope channel is not being brushed during the manual cleaning.All their personnel in charge of reprocessing the device are properly trained.The device was working properly prior to the reported failure.Instructions for use (ifu) states: ¿before reprocessing, thoroughly review this manual and the manuals of the reprocessing equipment and chemicals that will be used for reprocessing.Reprocess all the devices as instructed.¿ the investigation has been completed.A device history record (dhr) was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.
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Search Alerts/Recalls
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