Model Number TJF-Q180V |
Device Problem
Residue After Decontamination (2325)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device in this report has not been investigated by the manufacturer yet.Therefore the exact cause of the reported has not been conclusively determined.This report will be supplemented once the investigation has been concluded.
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Event Description
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A technical service engineer of olympus medical systems (b)(4) private limited reported that foreign materials adhered to the distal end of the device.No patient was involved in this event.The device was inspected by olympus because the customer reported that the device failed a leakage testing due to a damage on the bending section after an endoscopy.There is no other information provided at this moment.This report will be supplemented if additional information is available.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The field service engineer (fse) of olympus informed that the user facility had conducted reprocessing according to our recommendation.The fse will arrange one more reprocessing training for the user facility.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.
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Search Alerts/Recalls
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