OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE; TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)
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Model Number A70940A |
Device Problem
Poor Quality Image (1408)
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Patient Problem
Injury (2348)
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Event Date 10/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that an unspecified diagnostic procedure, the endoscopic image of the subject device was blurred due to the temperature difference between the subject device and body temperature after the subject device was inserted into the ear canal.The patient¿s ear canal was damaged by the subject device and got bleeding when the subject device was being withdrawn from the patient¿s ear canal.The user facility conducted an unspecified hemostasis.There was no report of further patient injury with the event.
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Manufacturer Narrative
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Additional information: d4 - serial number; h4 - device manufacturer date; device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the telescope without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.
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