OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°; HF-RESECTION ELECTRODES
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Model Number A22251A |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device was returned to the manufacturer for evaluation/investigation.However, the exact cause of the user's experience and the reported phenomenon could not be determined yet since the evaluation/investigation is still ongoing.As soon as the investigation results and final evaluation are 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 the bladder (turb) procedure, the wire holding the roller at the distal end of the hf resection electrode broke, and the roller detached and fell inside the patient's bladder.However, no fragment remained inside the patient since the roller ball was reportedly retrieved.The intended procedure was successfully completed with another hf resection electrode and there was no report of any adverse event or patient injury.
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Manufacturer Narrative
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The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the roller at the distal end of the hf resection electrode is detached.This damage is most likely caused by using the monopolar hf resection electrode in bipolar mode.Therefore, this event/incident was attributed to abnormal use/off-label use.Furthermore, 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 event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
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