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
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2022 |
Event Type
malfunction
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Event Description
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Olmypus was informed that during preparation for a therapeutic transurethral resection in saline (turis) procedure, when the sterilized pack of the hf resection electrode was opened, the loop wire (blue and yellow contact) at the distal end of the electrode got deformed.The intended procedure was completed using another 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 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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Search Alerts/Recalls
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