OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", SMALL LOOP, 24 FR., 12-30, IN SALINE; HF-RESECTION ELECTRODES
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Model Number WA22305S |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/01/2020 |
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 transurethral resection of a bladder tumor (turbt) procedure, the loop wire at the distal end of the hf resection electrode broke and fragments may have fallen into the patient¿s bladder.This happened when the esg-400 generator was unplugged, and restarted after it had performed an automatic restart.The intended procedure was completed using a similar device, and there was no report about an adverse event or patient injury.
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Manufacturer Narrative
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The suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical system corporation in hinode, japan (omsc), (returned to omsc on 2020-10-09).The evaluation at omsc hinode confirmed that the loop wire at the distal end of the electrode is broken and that the ends of the wire have melted into balls.The damage found was attributed to use-related wear and tear.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 electrode 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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