OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24-28 FR.,45° ANGLED; HF-RESECTION ELECTRODES
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Model Number WA22558C |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/18/2018 |
Event Type
malfunction
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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 enucleation of the prostate with bipolar (tueb) procedure, the loop wire of the hf resection electrode broke off and fell inside the patient's bladder.It is assumed that the fragment was flushed out with irrigation fluid since no foreign objects were discovered inside the bladder.The intended procedure was successfully completed with the same set of equipment 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 was not returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be conclusively determined.However, it was reported that the single-use hf resection electrode had been reprocessed and reused on the patient.It is very likely that as a result of it being reused and reprocessed, the electrode¿s loop wire had become less durable to withstand applied force and it thus broke.Therefore, this event/incident was attributed to use error.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.The case will be closed on olympus side with no further actions.However, 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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