Model Number ENF-VT2 |
Device Problem
Break (1069)
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Patient Problem
Injury (2348)
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Event Date 10/21/2019 |
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 during an electronic laryngoscopy, the patient had a nose bleeding because the bending section of the subject device could not be straightened and the distal end damaged the patient's nasal septum.The user facility conducted an unspecified hemostasis due to the large amount of bleeding.There was no report of further patient injury with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.On december 13th, 2019, olympus followed up with the user facility and received detailed information of the procedure where the event occurred as follows; the endoscopic image of the subject device disappeared when the bending section of the subject device was angulated.The user facility immediately stopped the procedure and removed the subject device from the patient when the endoscopic image of the subject device disappeared.The patient complained of discomfort during the procedure.The patient was discharged from the user facility after the procedure.The user facility continues to use the subject device.The subject device has been repaired by a third party company.It was reported that the serial number of the subject device is (b)(6), not (b)(6).Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined because the subject device was not returned omsc for evaluation and the subject device was repaired by the third party company.
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Search Alerts/Recalls
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