Model Number GF-UE160-AL5 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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During a yearly preventative maintenance of the ultrasonic gastrovideoscope, an olympus field service engineer discovered that the acoustic lens protection on the distal end of the scope was missing.There was no patient involvement, no harm or user injury reported due to the event.
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Manufacturer Narrative
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Olympus is not aware of how long the scope has been used without the acoustic lens protection.The customer was advised that it is not safe to use the scope and an informative offer of the cost to repair the scope was sent.The device has not been received to date.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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Event Description
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During a yearly preventative maintenance of the ultrasonic gastrovideoscope, an olympus field service engineer discovered that the acoustic lens protection on the distal end of the scope was missing.There was no patient involvement, no harm or user injury reported due to the event.
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Manufacturer Narrative
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Olympus is not aware of how long the scope has been used without the acoustic lens protection.The customer was advised that it is not safe to use the scope and an informative offer of the cost to repair the scope was sent.The device has not been received to date.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.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 yearly preventative inspection of customer equipment, the surface of the acoustic lens was found damaged.Damages were observed in the distal end.Therefore, it was possible that external force was applied to the distal end.The following information were also obtained from the investigation: · insertion tube is deformed · video cable is deformed · the product met its standards at the time it was shipped the instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿ do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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