Model Number TJF-260V |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to 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 inspected the device at the service department of olympus (b)(4) and found that some of the wires that composed the forceps elevator wire of the device were cut and raised.There was no report of patient injury associated with this event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.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.Based upon the information from olympus singapore there was the possibility that the reported phenomenon was attributed to the following occurrence mechanisms.The reported phenomenon was attributed to metal fatigue due to repeated stress.The forceps elevator was operated by excessive force using endo-therapy accessory which is not applicable.An excessive force was applied to insert or remove the endo-therapy accessory with the forceps raised.
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Search Alerts/Recalls
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