OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, BAND, 24 FR., 30°, STERILE, SINGLE USE, 12 PCS.; HF-RESECTION ELECTRODES
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Model Number A22223C |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/10/2019 |
Event Type
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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Event Description
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Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the loop electrode¿s cutting performance was perceived as insufficient.As a result, the intended procedure was canceled and will have to be rescheduled.No further information was provided but there was no adverse event or patient injury during the procedure.
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Manufacturer Narrative
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The suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the manufacturer's evaluation was exclusively performed on the basis of the provided information.According to the available documentation, the end user reports an insufficient power delivered by the 30° hf-resection electrode.It was also reported that an inspection of the electrode was conducted prior to the procedure where no abnormalities were found.Furthermore, a manufacturing and quality control review was performed for the affected lot number of the hf-resection electrode without showing any abnormalities.Therefore, this event/incident was attributed to use error.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
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