OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°; HF-RESECTION ELECTRODES
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Model Number A22201A |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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There was no device 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.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 from olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.
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Event Description
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Olympus was informed that during a therapeutic transcervical resection (tcr) procedure, the loop wire at the distal end of the hf resection electrode broke off.This occurred several months ago and the fragment could not be located at that time.Therefore, it is also unknown if the fragment broke off and fell inside the patient.However, the intended procedure was successfully completed with another hf resection electrode and there was no report about an adverse event or patient injury.
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Search Alerts/Recalls
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