Model Number MLE-28-012 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.The cause of the reported event could not be determined at this time.
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Event Description
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Olympus was informed that during a therapeutic procedure, three cutting loops broke off and fell into the patient.It was reported that the surgeon retrieved all the device fragments.The intended procedure was completed with a fourth cutting loop.There was no patient injury reported.This is report 3 of 3.
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Manufacturer Narrative
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This supplemental report is being submitted to correct the previous reported mdr event.Additional information received from the user facility states that only one model: (b)(6) cutting loop failed during the procedure and not three.Please cross reference mfr.#(b)(4).
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Search Alerts/Recalls
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