OLYMPUS WINTER & IBE GMBH VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING; HF-ELECTRODES
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Model Number WA47787A |
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 10/14/2021 |
Event Type
malfunction
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Event Description
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Olympus was informed that during a therapeutic hysteroscopic myomectomy procedure the loop wire at the distal end of two hf electrodes of the same lot broke off and fell into the patient.However, no fragments remained inside the patient since they were reportedly retrieved.As a result of the failure, the procedure time was prolonged by approx.20 minutes but the intended procedure was completed 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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Manufacturer Narrative
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The suspect medical devices were returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the loop wires at the distal end of the two hf electrodes are broken off due to brittle failure.Thus, the reported event/incident was attributed to component failure.This is a known error pattern, which has already been examined in the past.However, it was assessed that a material change was not required based on the very low number of occurrences of this failure mode.A manufacturing and quality control review was performed for the affected lot number of the hf resection electrodes without showing any abnormalities.The case will be closed on olympus side with no further actions.However, the reported phenomenon 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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