OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number WA22302D |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Code Available (3191)
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Event Date 08/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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The suspect medical device has not yet been 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, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
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Event Description
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Olympus was informed that during an unspecified therapeutic procedure, the cutting performance of multiple hf resection electrodes of two different lot numbers was reported to have been very poor.As a result, the intended procedure could not be completed successfully and a follow-up procedure was performed on (b)(6) 2020.
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Manufacturer Narrative
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The suspect medical device was not returned to the manufacturer for evaluation/investigation since it was reportedly discarded by the user facility.Instead, two other electrodes of the same lot number were returned.The evaluation/investigation confirmed that both returned electrodes are in standard condition.Therefore, the cause of the reported event could not be conclusively determined.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf resection electrode without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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