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 Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the exact cause of the user's experience and the reported phenomenon could not be conclusively determined and is being judged as unknown.However, the reported failure is a known phenomenon caused by wear and tear.The loop at the distal end of the hf electrode may wear out during use and may break, burn or melt.Thus, this incident can most likely be attributed to use error.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 from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.
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Event Description
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Olympus was informed that during a unspecified hysteroscopy procedure the loop wire at the distal end of the resection electrode melted.It could not be confirmed that a fragment broke off and fell into the patient.No further information was provided but there was no report about an adverse event or patient injury.
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Search Alerts/Recalls
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