OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
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Model Number WA22302D |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the evaluation found the electrode was broken and not fused, during output, the electrode unexpectedly came into contact with other (metal) instruments, there were foreign objects and impurities attached to the surface of the loop, the liquid surface area in contact with the loop was relatively small, and repeated cutting of the electrodes lead to wear.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus, the high frequency-resection electrode, loop, was worn out on the distal end.The issue was found during a therapeutic, electroresection of the prostate.The procedure was completed with a similar device.There were no reports of patient harm.
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Search Alerts/Recalls
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