OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12, STERILE,; HF-RESECTION ELECTRODES
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Model Number WA22302D |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Information (3190)
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Event Date 08/03/2020 |
Event Type
malfunction
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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 user's experience 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 a therapeutic cervical surgery, the loop wire at the distal end of two hf resection electrodes of the same lot-number broke.The intended procedure was canceled and an ultrasound examination is to be scheduled to check if fragments possibly remained inside the patient¿s body.
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Manufacturer Narrative
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The suspect medical devices were not returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be conclusively determined and is being judged as unknown.However, based on the customer's description and our experience, the reported damage was most likely caused by use-related wear and tear in combination with excessive force.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection electrodes without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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Search Alerts/Recalls
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